FDA Adverse Event
Other
Summary report: N
GOLDENBERG HAPEX TORP
MDR report key: 1051772
·
Received May 19, 2008
Report
- Report Number
- 1037007-2008-00004
- Event Type
- Other
- Date Received
- May 19, 2008
- Report Date
- May 19, 2008
- Manufacturer
- GYRUS ENT
- Product Code
- ETB
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
FINDINGS: THE RETURNED IMPLANT HAS A BROKEN SHAFT FROM HANDLING. THE IMPLANT HAS BLOOD AND DEBRIS ON IT, AND HANDLING MARKS ON THE SHAFT. THE SHAFT BASE STILL ATTACHED TO THE IMPLANT HEAD IS SLIGHTLY BENT.
Description of Event or Problem · 1
DURING SURGERY, THE IMPLANT BROKE IN THE PT'S EAR. THE PT WAS NOT INJURED. THE SURGERY WAS STOPPED. THE PT WAITED AT THE FACILITY WHILE A REPLACEMENT IMPLANT WAS OBTAINED, AND THE SURGERY WAS COMPLETED 3.5 HRS LATER WITH NO FURTHER PROBLEMS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | GOLDENBERG HAPEX TORP | TORP | ETB | GYRUS ENT | 0742311329 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |