FDA Adverse Event
Malfunction
Summary report: N
GLOBAL UNITE TR BODY SZ14 135
MDR report key: 7049863
·
Received November 21, 2017
Report
- Report Number
- 1818910-2017-29574
- Event Type
- Malfunction
- Date Received
- November 21, 2017
- Date of Event
- June 21, 2017
- Report Date
- June 21, 2017
- Manufacturer
- DEPUY IRELAND - 9616671
- Product Code
- LHX
- UDI-DI
- 10603295416098
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SW
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
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.
Additional Manufacturer Narrative · 1
IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.
Description of Event or Problem · 1
SYNERGY STATES THAT THE GREEN COLOUR WAS LOOSE AND FELL APART BUT OUTSIDE THE PATIENT AND AFTER IT HAS BEEN USED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 829785 | GLOBAL UNITE TR BODY SZ14 135 | MISC EXTREMITY INSTRUMENT/TRIAL | LHX | DEPUY IRELAND - 9616671 | NW148537 | 10603295416098 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |