MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,07 report with the FDA on 2013-03-29 for UNILOCK RECOPL 2.4 ANGL W/COND-HEAD R 18 449.646 manufactured by Synthes Usa.
[3321160]
A device report from synthes (b)(4) indicated a hospital in (b)(6) reported: reconstruction surgery was performed in 2011. Patient was implanted with reconstruction plate and screws. After two years, the plate was found broken; removed: (b)(6) 2013.
Patient Sequence No: 1, Text Type: D, B5
[10587590]
The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.
Patient Sequence No: 1, Text Type: N, H10
[20000737]
This is 1 of 1 report for complaint (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[20484398]
This device used for treatment and not diagnosis. The measurable dimensions were checked and found to be in compliance with the technical drawings and ao asif specification. The examination of the raw-material testing certificate and the manufacturing papers was not possible as the lot number was not provided. Basically the values should be in compliance with ao asif specification and with the international standard iso 5832-2 for ticp. The fracture face of the plate is homogenous, which indicates material conformity. No product fault could be detected and we are not aware of any other complaint for the article number. Based on the provided information we suppose that the plate had to absorb and neutralize forces over a long period of time, which can lead to a material fatigue and finally to the breakage of an implant.
Patient Sequence No: 1, Text Type: N, H10
[30694312]
(b)(4)
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2520274-2013-01747 |
| MDR Report Key | 3027140 |
| Report Source | 01,07 |
| Date Received | 2013-03-29 |
| Date of Report | 2013-03-01 |
| Date of Event | 2013-02-20 |
| Date Mfgr Received | 2014-10-16 |
| Date Added to Maude | 2013-03-29 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | LINDA PLEWS |
| Manufacturer Street | 1302 WRIGHTS LANE EAST |
| Manufacturer City | WEST CHESTER PA 19380 |
| Manufacturer Country | US |
| Manufacturer Postal | 19380 |
| Manufacturer Phone | 8006207025 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UNILOCK RECOPL 2.4 ANGL W/COND-HEAD R 18 |
| Product Code | NEI |
| Date Received | 2013-03-29 |
| Returned To Mfg | 2013-03-07 |
| Catalog Number | 449.646 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SYNTHES USA |
| Manufacturer Address | WEST CHESTER PA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2013-03-29 |