MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-11-21 for GLOBAL UNITE TR BODY SZ14 135 210050015 manufactured by Depuy Ireland - 9616671.
[92952333]
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
[92952334]
Synergy states that the green colour was loose and fell apart but outside the patient and after it has been used.
Patient Sequence No: 1, Text Type: D, B5
[118558991]
Product complaint # :(b)(4). Investigation summary : examination of the returned device confirmed the reported event. Depuy considers the investigation closed at this time. Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary. If information is obtained that was not available for the initial medwatch , a follow-up medwatch, a follow-up medwatch will be filed as appropriate.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1818910-2017-29574 |
| MDR Report Key | 7049863 |
| Date Received | 2017-11-21 |
| Date of Report | 2017-06-21 |
| Date of Event | 2017-06-21 |
| Date Mfgr Received | 2018-07-25 |
| Device Manufacturer Date | 2014-02-11 |
| Date Added to Maude | 2017-11-21 |
| 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 | MR. CHAD GIBSON |
| Manufacturer Street | 700 ORTHOPAEDIC DRIVE |
| Manufacturer City | WARSAW IN 46582 |
| Manufacturer Country | US |
| Manufacturer Postal | 46582 |
| Manufacturer Phone | 5743725905 |
| Manufacturer G1 | DEPUY ORTHOPAEDICS, INC. 1818910 |
| Manufacturer Street | 700 ORTHOPAEDIC DRIVE |
| Manufacturer City | WARSAW 46582 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 46582 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | GLOBAL UNITE TR BODY SZ14 135 |
| Generic Name | MISC EXTREMITY INSTRUMENT/TRIAL |
| Product Code | LHX |
| Date Received | 2017-11-21 |
| Returned To Mfg | 2017-10-25 |
| Catalog Number | 210050015 |
| Lot Number | NW148537 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DEPUY IRELAND - 9616671 |
| Manufacturer Address | LOUGHBEG RINGASKIDDY CO. CORK EI |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-11-21 |