MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,consum report with the FDA on 2019-08-15 for 3.5MM TI LCP? PROXIMAL HUMERUS PLATE-STANDARD 3H SHAFT/90MM 441.901 manufactured by Oberdorf Synthes Produktions Gmbh.
[154431565]
Complainant part is not expected to be returned for manufacturer review/investigation. Reporter is a synthes employee. Without a lot number the device history records review could not be completed. Product was not returned. Based on the information available, it has been determined that no corrective and/or 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
[154431566]
Device report from (b)(6) reports an event as follows: it was reported that patient will undergo revision surgery on an unknown date due to pain. Patient originally suffered a skiing accident approximately two and a half (2. 5) years ago and the humerus and tibia were reconstructed with plate, nail, and screws. Surgical consultant believes that some of the tibial screws may be too long and may be causing pain. This report is for a 3. 5mm titanium (ti) locking compression plate (lcp)? Proximal humerus plate. This is report 9 of 10 for (b)(4). Additional reports are captured under (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8030965-2019-67273 |
| MDR Report Key | 8897053 |
| Report Source | COMPANY REPRESENTATIVE,CONSUM |
| Date Received | 2019-08-15 |
| Date of Report | 2019-07-19 |
| Date Mfgr Received | 2019-10-10 |
| Date Added to Maude | 2019-08-15 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | KARA DITTY-BOVARD |
| Manufacturer Street | 1302 WRIGHTS LANE EAST |
| Manufacturer City | WEST CHESTER PA 19380 |
| Manufacturer Country | US |
| Manufacturer Postal | 19380 |
| Manufacturer Phone | 6103142063 |
| 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 TI LCP? PROXIMAL HUMERUS PLATE-STANDARD 3H SHAFT/90MM |
| Generic Name | APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBO, SINGLE COMPONENT |
| Product Code | KTW |
| Date Received | 2019-08-15 |
| Catalog Number | 441.901 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| 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 | 2019-08-15 |