D
Patient 1
REP REPORTED THAT THE PERFORATOR DID NOT STOP WHEN GOT BEYOND THE CRANIAL BONE, WHICH RESULTED IN TORN DURA.
MAUDE MDR 923921
- MDR report key
- 923921
- Report number
- 1226348-2007-00263
- Event key
- 0
- Event type
- 3
- Date received
- 2007-10-09
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 0
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 0
Manufacturer Contact#
- Contact
- MATTHEW KING
- Address
- 325 PARAMOUNT DR. RAYNHAM MA 02767 US
- Phone
- 508-508-5088
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | CODMAN DISPOS PERFORATOR | DRILLS, BURRS, TREPHINES, & ACC. | CODMAN & SHURTLEFF, INC. | KAT | NA | 26-1221 | UNK | N | N | R |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2007-10-09 | 0 | 1. R |
Event Narratives#
N
Patient 1
HISTORICALLY FOR COMPLAINTS OF THIS NATURE, THE RETURNED PERFORATORS HAVE BEEN VISUALLY INSPECTED AS RECEIVED, DISASSEMBLED AND CLEANED, AND THEN VISUALLY AND DIMENSIONALLY INSPECTED. NO DISCREPANCIES HAVE BEEN FOUND. THE PERFORATORS HAVE BEEN REASSEMBLED AND WERE FUNCTIONALLY TESTED FOR CUTTING AND DRILLING. THEY'VE BEEN FOUND TO MEET SPECIFICATION REQUIREMETNS. THE REPORTED CONDITION COULD NOT BE DUPLICATED. REVIEWS OF THE DEVICE HISTORY RECORDS HAVE FOUND NO DISCREPANCIES. THE COMPLAINTS HAVE NOT BEEN CONFIRMED. A FOLLOW UP REPORT WILL BE FILED IF THE INVESTIGATION OF THIS DEVICE REVEALS A RESULT DIFFERENT FROM THAT WHICH IS STATED ABOVE OR IF ANY FURTHER INFORMATION REGARDING THE CAUSE OR MODE OF FAILURE IS MADE AVAILABLE. OTHERWISE, THE COMPLAINT IS CONSIDERED TO BE CLOSED AT THIS TIME.