FDA Adverse Event
Malfunction
Summary report: N
SHOULDER TOWER SUSPENSION SYSTEM
MDR report key: 6199277
·
Received December 22, 2016
Report
- Report Number
- 1221538-2016-00003
- Event Type
- Malfunction
- Date Received
- December 22, 2016
- Date of Event
- November 22, 2016
- Report Date
- December 22, 2016
- Manufacturer
- ALLEN MEDICAL SYSTEMS, INC.
- Product Code
- FMP
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- SERVICE PERSONNEL
Narratives
Additional Manufacturer Narrative · 1
AWAITING THE RETURN OF THE DEVICE FOR ROOT CAUSE EVALUATION, REMEDIATION DETERMINATION AND IMPLEMENTATION. A FOLLOW-UP MDR WILL BE FILED.
Description of Event or Problem · 1
FAIRLY EARLY IN THE CASE. PRIOR TO ANCHOR PLACEMENT. THEY TRIED TO ADJUST INTERNAL/EXTERNAL ROTATION SEVERAL TIMES. THE RIVETED SCREW ON THE BOOM FELL OUT AND INTO THE STERILE FIELD. THERE WAS NO KNOWN INJURY/ADVERSE EVENT TO THE PATIENT DUE TO THIS INCIDENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 847863 | SHOULDER TOWER SUSPENSION SYSTEM | SHOULDER TOWER | FMP | ALLEN MEDICAL SYSTEMS, INC. | AR-1650-01 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |