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 2020-01-17 for 4.5MM VA-LCP CURVED CONDYLAR PLATE/12 HOLE/266MM/RIGHT 02.124.412 manufactured by Wrights Lane Synthes Usa Products Llc.
[176065896]
Product complaint # (b)(4). Its employees caused or contributed to the potential event described in this report. Additional pro-code: 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 at the time of filing this report. A review of the device history record has been requested. 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
[176065897]
It was reported that on (b)(6) 2019, the patient underwent a revision of a broken variable angle (va) locking compression plate (lcp) condylar plate of a distal femur. The original date of implant was on (b)(6) 2019. Procedure and patient outcome are unknown. Concomitant device reported: unknown screws (part # unknown, lot # unknown, quantity unknown). This complaint involves one (1) device. This report is 1 of 1 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2939274-2020-00282 |
| MDR Report Key | 9604398 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-01-17 |
| Date of Report | 2019-12-24 |
| Date of Event | 2019-01-01 |
| Date Mfgr Received | 2020-01-24 |
| Device Manufacturer Date | 2018-11-02 |
| Date Added to Maude | 2020-01-17 |
| 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 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/12 HOLE/266MM/RIGHT |
| Generic Name | IMPLANT,FIXATION DEVICE, CONDYLAR PLATE |
| Product Code | JDP |
| Date Received | 2020-01-17 |
| Model Number | 02.124.412 |
| Catalog Number | 02.124.412 |
| Lot Number | 2L10473 |
| 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 | 2020-01-17 |