D
Patient 1
THE DEVICE (PART #: MCO13C) WAS RETURNED FOR REPAIR TO MXI SERVICE AND REPAIR.
MAUDE MDR 3337898
- MDR report key
- 3337898
- Report number
- 9680837-2013-00251
- Event key
- 0
- Event type
- 3
- Date of event
- 2012-09-14
- Date received
- 2013-08-29
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 401
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 0
Manufacturer Contact#
- Contact
- JONATHAN SCHLECH
- Address
- 6743 SOUTHPOINT DR N. JACKSONVILLE FL 32216 US
- Phone
- 904-904-9043
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | FORCEPS MCO13C ALLIG 3X0.6MM HARTMAN | MEDTRONIC XOMED INSTRUMENTATION S.A.S. | KAE | MCO13C | 03-04 | Y | Y |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2013-08-29 | 0 |
Event Narratives#
N
Patient 1
(B)(4). EVALUATION OF THIS INSTRUMENT INDICATED THAT THE MOBILE JAW WAS BROKEN AND BENT. THE FORCEPS WERE MOST LIKELY SUBJECTED TO IMPACT, WHICH CREATED THE BREAKAGE. NOTE: THIS MDR IS BEING FILED AS A RESULT OF AN INTERNAL REVIEW OF COMPLAINTS FROM MEDTRONIC'S MXI FACILITY IN (B)(4). THIS REVIEW WAS CONDUCTED TO RESOLVE SEVERAL ISSUES DISCOVERED IN THE MXI COMPLAINT HANDLING PROCESS. ISSUES RESOLVED INCLUDE THE MISCLASSIFICATION OF DEVICES RETURNED FOR REPAIR, AS WELL AS GAPS IN REPORTING. (B)(4).