FDA Adverse Event
Injury
Summary report: N
OSTEOSET® RESORBABLE MINI BEAD
MDR report key: 4917053
·
Received July 15, 2015
Report
- Report Number
- 1043534-2015-00040
- Event Type
- Injury
- Date Received
- July 15, 2015
- Date of Event
- June 16, 2015
- Manufacturer
- WRIGHT MEDICAL TECHNOLOGY, INC.
- Product Code
- MQV
- PMA / PMN Number
- K963587
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE INVESTIGATION IS NOT YET COMPLETE. TRENDS WILL BE EVALUATED. THIS REPORT WILL BE UPDATED WHEN THE INVESTIGATION IS COMPLETE.
Description of Event or Problem · 1
ALLEGEDLY, DURING THE USE OF BIOLOGIC BEADS ON AN AMPUTATION, THE VIAL WITH LIQUID IN IT WOULD NOT OPEN AFTER 30 MIN OF TRYING AND EXTENDED SURGERY GREATER THAN 30 MINUTES. THERE WAS A BACKUP DEVICE AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 458649 | OSTEOSET® RESORBABLE MINI BEAD | BONE VOID FILLER | MQV | WRIGHT MEDICAL TECHNOLOGY, INC. | 1548052 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |