N
Patient 1
THE DEVICE INVOLVED IN THE REPORTED INCIDENT IS NOT AVAILABLE FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION.
MAUDE MDR 6583287
- MDR report key
- 6583287
- Report number
- 3004170064-2017-00006
- Event key
- 0
- Event type
- 3
- Date received
- 2017-05-22
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 0
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Contact
- USER SONIA IRIZARRY
- Address
- 311 ENTERPRISE DRIVE PLAINSBORO NJ 08536 US
- Phone
- 609-609-6099
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | PRIMATRIX, UNKNOWN SIZE/PRODUCT ID | PRIMATRIX | TEI BIOSCIENCES INC | KGN | XXX-PRIMATRIX | R | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2017-05-22 | 0 | 1. O |
Event Narratives#
D
Patient 1
ONE OF 2 REPORTS - OTHER MFG REPORT NUMBER: 3004170064-2017-00002. IT WAS REPORTED BY THE PATIENT, AN UNCOMFORTABLE FEELING WITH PRIMATRIX IN LEFT LEG. APPEARS HARD, ROCK LIKE AND SQUARE SHAPE IMPRINT. REMAINS IMPLANTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
N
Patient 1
INTEGRA HAS COMPLETED THEIR INTERNAL INVESTIGATION ON JUNE 7, 2017. RESULTS: DEVICE HAS BEEN IMPLANTED AND WILL NOT BE RETURNED FOR EVALUATION, THEREFORE FAILURE ANALYSIS CANNOT BE PERFORMED. DHR REVIEW; LOT NUMBER NOT SPECIFIED, THEREFORE DHR REVIEW CANNOT BE COMPLETED. COMPLAINTS HISTORY; COMPLAINT OCCURRENCE RATE: ONE COMPLAINT OF (B)(4) UNITS SOLD FROM APRIL 2016-APRIL 2017 RESULTS IN AN OCCURRENCE RATE OF (B)(4). CONCLUSION: DEVICE HAS BEEN IMPLANTED AND WILL NOT BE RETURNED FOR EVALUATION, THEREFORE ROOT CAUSE ANALYSIS CANNOT BE PERFORMED.