MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2019-05-31 for 3.5MM LCP? PROXIMAL HUMERUS PLATE-STANDARD 5H SHAFT/114MM 241.903 manufactured by Oberdorf Synthes Produktions Gmbh.
[146663267]
Device is expected to be returned for manufacturer review/investigation, but has not been received yet. (b)(4). Product was not returned. Device history records review could not be completed without lot number. Based on the information available, it has been determined that no corrective and preventative action is proposed. This complaint will be accounted for and monitored via post market surveillance activities. If additional information is made available, the investigation will be updated as applicable. Device was used for treatment, not diagnosis. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Patient Sequence No: 1, Text Type: N, H10
[146663268]
Device report from (b)(6) reports an event as follows: it was reported that on an (b)(6) 2019, the patient underwent a removal surgery due to a detached implant. Radiographic images confirmed a proximal humeral internal locking system (philos) proximal humeral plate with blocked six (6) locking screws and one (1) cortex screw disengaged from the plate in the proximal distal area with secondary loss of reduction. All devices were successfully explanted without any issues. The doctor makes new reduction using demineralized bone matrix (dbx) putty grafts and new philos plate using block guides for philos. Originally, the patient underwent an osteosynthesis of proximal humerus with philos plate last (b)(6) 2018. There was no surgical delay and the procedure was successfully completed. The patient was stable. This report is for one (1) proximal humerus plate. This is report 1 of 8 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8030965-2019-64726 |
| MDR Report Key | 8658651 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-05-31 |
| Date of Report | 2019-05-02 |
| Date Mfgr Received | 2019-07-02 |
| Device Manufacturer Date | 2018-04-30 |
| Date Added to Maude | 2019-05-31 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | KARA DITTY-BOVARD |
| Manufacturer Street | 1302 WRIGHT LANE EAST |
| Manufacturer City | WEST CHESTER PA 19380 |
| Manufacturer Country | US |
| Manufacturer Postal | 19380 |
| Manufacturer Phone | 6107195000 |
| Manufacturer G1 | WERK RARON (CH) |
| Manufacturer Street | KANALSTRASSE WEST 30 |
| Manufacturer City | RARON 3942 |
| Manufacturer Country | SZ |
| Manufacturer Postal Code | 3942 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 3.5MM LCP? PROXIMAL HUMERUS PLATE-STANDARD 5H SHAFT/114MM |
| Generic Name | APPLIANCE,FIXATION,NAIL/BLADE/PLATE COMBO, SINGLE COMPONENT |
| Product Code | KTW |
| Date Received | 2019-05-31 |
| Returned To Mfg | 2019-06-05 |
| Catalog Number | 241.903 |
| Lot Number | L856082 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OBERDORF SYNTHES PRODUKTIONS GMBH |
| Manufacturer Address | EIMATTSTRASSE 3 OBERDORF 4436 SZ 4436 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-05-31 |