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 2020-01-16 for 4.5MM VA-LCP CURVED CONDYLAR PLATE/6 HOLE/159MM/LEFT 02.124.407 manufactured by Wrights Lane Synthes Usa Products Llc.
[188339868]
Additional product code: hwc, hrs. Investigation summary: product was not returned. Based on the information available, it has been determined that no corrective and 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 history lot: part: 02. 124. 407, lot: 9505744, manufacturing site: (b)(4), release to warehouse date: june 15, 2015. A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified. 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
[188339869]
T was reported that on (b)(6) 2019, patient underwent hardware removal of two (2) variable angle locking compression plate (va-lcp) condylar plate and sixteen (16) unknown locking screws due to pain. Originally, the patient had bilateral osteotomies on unknown date. However, the patient was experiencing pain when performing squats. Thus, removal was done successfully. There was no patient consequence reported. This is report 2 of 10 for (b)(4). Related product complaint: (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2939274-2020-00220 |
| MDR Report Key | 9596265 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-01-16 |
| Date of Report | 2019-12-23 |
| Date Mfgr Received | 2019-12-23 |
| Device Manufacturer Date | 2015-06-15 |
| Date Added to Maude | 2020-01-16 |
| 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 | 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/6 HOLE/159MM/LEFT |
| Generic Name | IMPLANT,FIXATION DEVICE, CONDYLAR PLATE |
| Product Code | JDP |
| Date Received | 2020-01-16 |
| Model Number | 02.124.407 |
| Catalog Number | 02.124.407 |
| Lot Number | 9505744 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2020-01-16 |