MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2008-05-19 for GOLDENBERG HAPEX TORP 70145917 manufactured by Gyrus Ent.
[874269]
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.
Patient Sequence No: 1, Text Type: D, B5
[8077714]
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.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1037007-2008-00004 |
| MDR Report Key | 1051772 |
| Report Source | 05,06 |
| Date Received | 2008-05-19 |
| Date of Report | 2008-05-19 |
| Date Mfgr Received | 2008-04-30 |
| Device Manufacturer Date | 2007-12-01 |
| Date Added to Maude | 2010-04-05 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MR DOLAN MILLS, QUAL ENGINEER |
| Manufacturer Street | 2925 APPLING RD. |
| Manufacturer City | BARTLETT TN 38133 |
| Manufacturer Country | US |
| Manufacturer Postal | 38133 |
| Manufacturer Phone | 9013730200 |
| Manufacturer G1 | GYRUS ENT |
| Manufacturer Street | 2925 APPLING RD. |
| Manufacturer City | BARTLETT TN 38133 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 38133 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | GOLDENBERG HAPEX TORP |
| Generic Name | TORP |
| Product Code | ETB |
| Date Received | 2008-05-19 |
| Returned To Mfg | 2008-04-30 |
| Catalog Number | 70145917 |
| Lot Number | 0742311329 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GYRUS ENT |
| Manufacturer Address | BARTLETT TN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2008-05-19 |