FDA Adverse Event
Injury
Summary report: N
CSS CANNULATED SCREW SYSTEM
MDR report key: 1831931
·
Received September 7, 2010
Report
- Report Number
- 3005039508-2010-00015
- Event Type
- Injury
- Date Received
- September 7, 2010
- Date of Event
- August 12, 2010
- Report Date
- August 12, 2010
- Manufacturer
- ORTHOHELIX SURGICAL DESIGN
- Product Code
- HWC
- PMA / PMN Number
- K060428
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WI, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
PER THE PRODUCT IFU, "POST-OPERATIVE CARE. NOTE: POSTOPERATIVE CARE IS EXTREMELY IMPORTANT. THE PATIENT MUST BE WARNED THAT NONCOMPLIANCE WITH POSTOPERATIVE INSTRUCTIONS COULD LEAD TO BREAKAGE OF THE IMPLANT REQUIRING REVISION SURGERY TO REMOVE THE DEVICE."
Description of Event or Problem · 1
PER THE SALES REP, THE SCREW BROKE APPROXIMATELY SIX MONTHS POST OPERATIVELY. THE SURGEON WAS DOING A LAPIDUS REVISION AND DISCOVERED THE BROKEN SCREW, SO THE SURGEON REMOVED THE BROKEN SCREW AND RE-IMPLANTED THE SAME SIZE SCREW TO REPLACE THE ONE THAT BROKE. THE SALES REP NOTED THAT THE PATIENT WAS NON-COMPLIANT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CSS CANNULATED SCREW SYSTEM | BONE FIXATION SCREWS | HWC | ORTHOHELIX SURGICAL DESIGN | MSD-010-40-040L |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |