MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2008-06-09 for DORNHOFFER 70145842 manufactured by Gyrus Ent.
[873085]
The device was implanted 2 years ago. Reportedly, the implant head has become separated from the shaft and therefore a revision surgery is required. The revision surgery has not taken place as of the date of this report.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1037007-2008-00008 |
| MDR Report Key | 1059595 |
| Report Source | 05,06 |
| Date Received | 2008-06-09 |
| Date of Report | 2008-06-09 |
| Date Mfgr Received | 2008-05-15 |
| Device Manufacturer Date | 2006-09-01 |
| Date Added to Maude | 2010-04-07 |
| 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 |
| 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 | DORNHOFFER |
| Generic Name | PORP |
| Product Code | ETB |
| Date Received | 2008-06-09 |
| Catalog Number | 70145842 |
| Lot Number | 0631081303 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GYRUS ENT |
| Manufacturer Address | BARTLETT TN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2008-06-09 |