FDA Adverse Event
Malfunction
Summary report: N
RELIANCE C DOUBLE SIDED RASP 7MM
MDR report key: 6055243
·
Received October 25, 2016
Report
- Report Number
- 0009617544-2016-00424
- Event Type
- Malfunction
- Date Received
- October 25, 2016
- Date of Event
- September 28, 2016
- Report Date
- January 13, 2017
- Manufacturer
- STRYKER SPINE-FRANCE
- Product Code
- LXH
- UDI-DI
- 07613327269888
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AR, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
LOT# 062182; VISUAL INSPECTION, DEVICE HISTORY REVIEW, COMPLAINT HISTORY REVIEW, RISK ASSESSMENT. THE DEVICE WAS INSPECTED AND IT WAS FOUND THAT THE HANDLE WAS FRACTURED. NO RELEVANT MANUFACTURING ISSUES WERE IDENTIFIED AS ALL UNITS MET STRYKER SPECIFICATIONS. DEVICE WAS FOUND TO BE MORE THAN 10 YEARS OLD. THE PROBABLE ROOT CAUSE OF THIS EVENT IS DETERMINED TO BE NORMAL WEAR AND TEAR OF INSTRUMENT.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING AN ANTERIOR CERVICAL FUSION A DOUBLE SIDED RASP CAME APART WHILE BEING FROM THE PATIENT 'S NECK.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING AN ANTERIOR CERVICAL FUSION A DOUBLE SIDED RASP CAME APART WHILE BEING FROM THE PATIENT 'S NECK.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 704220 | RELIANCE C DOUBLE SIDED RASP 7MM | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT | LXH | STRYKER SPINE-FRANCE | 062182 | 07613327269888 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 34 YR |