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 2019-05-09 for 4.5MM VA-LCP CURVED CONDYLAR PLATE/14HOLE/301MM/RT-STER 02.124.414S manufactured by Oberdorf Synthes Produktions Gmbh.
[144667011]
Additional pro-codes: hrs, hwc. Complainant part is not expected to be returned for manufacturer review/investigation. (b)(4). Without a lot number, the device history records review could not be completed as no product was received. The investigation could not be completed; no conclusion could be drawn at the time of filing this report. 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. 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
[144667012]
Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2019, a revision surgery was performed due to a nonunion and loss of position into varus. Originally, the patient underwent an implantation of variable angle (va) locking compression plate (lcp) condylar plate for gunshot injury to distal femur on late 2018. Thus, all implants were removed where in all unknown proximal screws were intact and was revised with an unknown angle blade plate with supporting medial small fragment plate. Looked like the distal screw plate interface had disconnected on four (4) unknown distal locking screws where in one (1) unknown distal locking screw was broken at the neck. There was no surgical delay. Surgical procedure was successfully completed. Patient status is unknown. Concomitant device reported: va locking screws (part # 02. 231. 230, lot# unknown, quantity 1); va locking screws (part # 02. 231. 234, lot# unknown, quantity 1); va locking screws (part # 02. 231. 275, lot# unknown, quantity 1); va locking screws (part # 02. 231. 280, lot# unknown, quantity 1); va locking screws (part # 02. 231. 285, lot# unknown, quantity 1); va locking screws (part # 02. 231. 290, lot# unknown, quantity 1) and unknown distal locking screws (part# unknown, lot# unknown, quantity 3). This complaint involves three (3) devices. This report is 1 of 3 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8030965-2019-63734 |
| MDR Report Key | 8597483 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-05-09 |
| Date of Report | 2019-04-11 |
| Date Mfgr Received | 2019-04-11 |
| Date Added to Maude | 2019-05-09 |
| 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 | EIMATTSTRASSE 3 |
| Manufacturer City | OBERDORF 4436 |
| Manufacturer Country | SZ |
| Manufacturer Postal | 4436 |
| Manufacturer Phone | 6103142063 |
| Manufacturer G1 | WERK MEZZOVICO (CH) |
| Manufacturer Street | VIA CAVAZZ 5 |
| Manufacturer City | MEZZOVICO 6805 |
| Manufacturer Country | SZ |
| Manufacturer Postal Code | 6805 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 4.5MM VA-LCP CURVED CONDYLAR PLATE/14HOLE/301MM/RT-STER |
| Generic Name | IMPLANT,FIXATION DEVICE, CONDYLAR PLATE |
| Product Code | JDP |
| Date Received | 2019-05-09 |
| Catalog Number | 02.124.414S |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2019-05-09 |