MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06,07 report with the FDA on 1999-04-20 for HOOKS manufactured by Synthes (usa).
[132099]
The subject devices were implanted on 3/1/99. On 3/20/99, while the pt was bending to vomit, the subject devices came loose from the concomitant devices. On 3/22/99, another surgery was performed to remove the subject devices and replace with new devices.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2520274-1999-00022 |
| MDR Report Key | 219474 |
| Report Source | 05,06,07 |
| Date Received | 1999-04-20 |
| Date of Report | 1999-03-23 |
| Date of Event | 1999-03-20 |
| Date Mfgr Received | 1999-03-23 |
| Date Added to Maude | 1999-04-21 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NI |
| Generic Name | HOOKS |
| Product Code | HNQ |
| Date Received | 1999-04-20 |
| Returned To Mfg | 1999-04-06 |
| Model Number | NA |
| Catalog Number | NI |
| Lot Number | NI |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | Y |
| Date Removed | V |
| Device Sequence No | 1 |
| Device Event Key | 212843 |
| Manufacturer | SYNTHES (USA) |
| Manufacturer Address | 1690 RUSSELL RD. PAOLI PA 19301 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1999-04-20 |