MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2019-02-11 for 4.5MM VA-LCP CURVED CONDYLAR PLATE/12HOLE/266MM/RT-STER 02.124.412 02.124.412S manufactured by Wrights Lane Synthes Usa Products Llc.
[135695020]
Additional procodes: hrs, hwc. Complainant part is not expected to be returned for manufacturer review/investigation. The investigation could not be completed; no conclusion could be drawn, as no product was received. 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. A device history record review has been requested. (b)(4). 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
[135695021]
It was reported that on (b)(6) 2019, the patient underwent hardware removal due to non-union and a broken variable angle locking compression (va-lcp) curved condylar distal femur plate. Ten (10) variable angle locking screws and three (3) cortex screws were also removed. The patient was originally treated with an open reduction and internal fixation (orif) surgery of a distal femur on an unknown date. The procedure was successfully completed with no surgical delay. Patient status was fine and good. Concomitant devices: va locking screws (part: unknown, lot: unknown, quantity: 10), 4. 5 cortex screws (part: unknown, lot: unknown, quantity: 3). This report is for a 4. 5mm va-lcp curved condylar plate. This is report 1 of 1 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2939274-2019-56383 |
| MDR Report Key | 8325209 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-02-11 |
| Date of Report | 2019-01-16 |
| Date Mfgr Received | 2019-04-30 |
| Device Manufacturer Date | 2018-03-06 |
| Date Added to Maude | 2019-02-11 |
| 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 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/12HOLE/266MM/RT-STER |
| Generic Name | IMPLANT, FIXATION DEVICE, CONDYLAR PLATE |
| Product Code | JDP |
| Date Received | 2019-02-11 |
| Model Number | 02.124.412 |
| Catalog Number | 02.124.412S |
| Lot Number | L773527 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | WRIGHTS LANE SYNTHES USA PRODUCTS LLC |
| Manufacturer Address | 1302 WRIGHTS LANE EAST WEST CHESTER PA 19380 US 19380 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-02-11 |