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 2018-01-12 for 3.5MM LCP? PROXIMAL HUMERUS PLATE-STANDARD 5H SHAFT/114MM 241.903 manufactured by Oberdorf : Synthes Produktions Gmbh.
[97116671]
Additional narrative: patient weight not available for reporting. Date of device breakage is not known. Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received. The investigation could not be completed; no conclusion could be drawn, as no product was received. 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
[97116672]
It was reported that patient underwent osteosynthesis of proximal humerus with a 3. 5mm locking compression plate (lcp) proximal humerus plate and seven (7) unknown screws on (b)(6) 2017. Procedure was completed successfully. Post-operatively it was noted the plate was broken. It was also noted that patient bone has necrosis. Revision surgery was performed on (b)(6) 2017 without any issues. Implants were removed. Patient will receive unspecified additional treatment prior to implanting new material. This report is for one (1) 3. 5mm lcp proximal humerus plate (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[115261108]
The device was received and the product evaluation is in progress. No conclusion can be drawn. 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
| Report Number | 8030965-2018-50316 |
| MDR Report Key | 7186520 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2018-01-12 |
| Date of Report | 2017-12-15 |
| Date Mfgr Received | 2018-03-13 |
| Device Manufacturer Date | 2017-05-05 |
| Date Added to Maude | 2018-01-12 |
| 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 | MICHAEL COTE |
| Manufacturer Street | 1302 WRIGHTS 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 | 2018-01-12 |
| Returned To Mfg | 2018-01-15 |
| Model Number | 241.903 |
| Catalog Number | 241.903 |
| Lot Number | L376756 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| 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 | 2018-01-12 |