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 2019-03-19 for 4.5MM VA-LCP CURVED CONDYLAR PLATE/12 HOLE/266MM/RIGHT 02.124.412 manufactured by Wrights Lane Synthes Usa Products Llc.
[139213470]
Date of event: event occurred on an unknown date in 2019. Additional product codes: hrs, hwc. (b)(4). Device evaluated by mfr, manufacture date, event problem and evaluation codes: device history lot: part: 02. 124. 412, lot: l824012, manufacturing site: (b)(4), release to warehouse date: 20. Mar. 2018. A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified. The raw material certificate (b)(4) was reviewed and the used material was according to specification for implants for surgery. 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
[139213471]
It was reported that the patient underwent removal of plate and screws on (b)(6) 2019, due to broken variable angle (va) locking compression plate (lcp) curved condylar right side at the 6th and 7th hole of the shaft of the plate. The patient has an original implant of nine (9) unknown locking screws and two (2) unknown cortex screws on (b)(6) 2019. The patient had been walking on it against the surgeons direction, and a partial weight bearing plate broke. All the implants were removed successfully and the patient was repaired with intramedullary retrograde antegrade femoral nail successfully. There was no surgical delay. Procedure was successfully completed. Patient outcome is unknown. Concomitant devices reported: unk - screws: locking (part# unknown; lot# unknown; quantity 9). Unk - screws: cortex (part# unknown; lot# unknown; quantity 2). This report is for one (1) 4. 5mm va-lcp curved condylar plate/12 hole/266mm/right. This is report 1 of 1 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5
Report Number | 2939274-2019-57022 |
MDR Report Key | 8432897 |
Report Source | COMPANY REPRESENTATIVE,HEALTH |
Date Received | 2019-03-19 |
Date of Report | 2019-02-25 |
Date of Event | 2019-01-01 |
Date Mfgr Received | 2019-04-26 |
Device Manufacturer Date | 2018-03-20 |
Date Added to Maude | 2019-03-19 |
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/12 HOLE/266MM/RIGHT |
Generic Name | IMPLANT,FIXATION DEVICE, CONDYLAR PLATE |
Product Code | JDP |
Date Received | 2019-03-19 |
Model Number | 02.124.412 |
Catalog Number | 02.124.412 |
Lot Number | L824012 |
Operator | HEALTH PROFESSIONAL |
Device Availability | N |
Device Eval'ed by Mfgr | N |
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 | 2019-03-19 |