FDA Adverse Event
Other
Summary report: N
SUMMIT SYSTEM
MDR report key: 294196
·
Received September 1, 2000
Report
- Report Number
- 1526439-2000-00014
- Event Type
- Other
- Date Received
- September 1, 2000
- Date of Event
- August 3, 2000
- Report Date
- August 31, 2000
- Manufacturer
- DEPUY ACROMED, INC.
- Product Code
- HWC
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
DEPUY ACROMED WAS INFORMED BY A SALES REP THAT 3 SUMMIT BONE SCREWS BROKE DURING INSERTION INTO THE SPINE. THE BROKEN PIECES OF THE SCREWS WERE LEFT IN THE BONE. IT WAS NOTED BY THE COMPLAINANT THAT THE BONE WAS EXTREMELY DENSE SO OVER-TORQUING OR EXCESSIVE FORCE COULD BE THE CAUSE OF THE BREAKAGE. THE BROKEN SCREWS WERE NOT RETURNED FOR EVALUATION. NO FURTHER EVALUATION CAN BE PERFORMED AT THIS TIME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SUMMIT SYSTEM | BONE SCREW | HWC | DEPUY ACROMED, INC. | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 44 YR | Other |