FDA Adverse Event
Malfunction
Summary report: N
TRANSLATOR IMPLANT HOLDER
MDR report key: 36793
·
Received August 30, 1996
Report
- Report Number
- 1030489-1996-00001
- Event Type
- Malfunction
- Date Received
- August 30, 1996
- Report Date
- October 17, 1996
- Manufacturer
- SOFAMORE DANEK GROUP
- Product Code
- HXW
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
AN INSTRUMENT BROKE DURING SURGERY. AS A CONSEQUENCE, THE SURGEON BELIEVES LESS CORRECTION OF THE SPINE OCCURRED RESULTING IN A DELAY OF THE SURGERY OF ABOUT 30 MINS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TRANSLATOR IMPLANT HOLDER | CD HORIZON INSTRUMENT | HXW | SOFAMORE DANEK GROUP | NA | 9536GB |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 22 YR | Other |