FDA Adverse Event
Malfunction
Summary report: N
DEPTH GAUGE FOR SCREWS: Ø4.5/6.5MM
MDR report key: 3123660
·
Received May 22, 2013
Report
- Report Number
- 0008031020-2013-00158
- Event Type
- Malfunction
- Date Received
- May 22, 2013
- Date of Event
- April 27, 2013
- Report Date
- April 27, 2013
- Manufacturer
- STRYKER OSTEOSYNTHESIS-SELZACH
- Product Code
- LXH
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
DEVICE WILL NOT BE RETURNED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE IT WILL BE REPORTED ON A SUPPLEMENTAL REPORT. DEVICE WILL NOT BE RETURNED.
Description of Event or Problem · 1
DURING OMEGA CHS SURGERY, DURING THE SIDE PLATE SCREW MEASUREMENT FOR THE FIRST SCREW, THE DEPTH GAUGE MEASUREMENT WAS 36MM. THE SURGEON USED 38 MM SCREW, BECAUSE HE ASSUMED THAT YOU NEED TO ADD 2MM. HOWEVER IT WAS TOO LONG. THE SECOND SCREW, THE MEASUREMENT WAS 36MM. THE SURGEON USED 36MM SCREW WITHOUT THE ADDITIONAL 2 PLUS MM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 226214 | DEPTH GAUGE FOR SCREWS: Ø4.5/6.5MM | INSTRUMENT | LXH | STRYKER OSTEOSYNTHESIS-SELZACH | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |