MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1993-08-01 for PAULUS CHIN PLATING SYSTEM manufactured by Walter Lorenz Surgical Inst. Co..
[19233914]
Pt. Had chin plate inserted on 7/20/93 (at that time x1 13mm screw broke off when md screwing wire used to compensate for broken head). X-rays taken - or on 7/22. Another panorex post-op x-ray taken revealed another bone screw id broken. Pt brought back to o. R.. Baseplate, 2 comple screws, 1 screw with head and 6mm piece of screw removed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 10317 |
| MDR Report Key | 10317 |
| Date Received | 1993-08-01 |
| Date of Report | 1993-07-26 |
| Date of Event | 1993-07-22 |
| Date Facility Aware | 1993-07-22 |
| Report Date | 1993-07-26 |
| Date Added to Maude | 1993-11-29 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| 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 | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PAULUS CHIN PLATING SYSTEM |
| Generic Name | TITANIUM BASE SCREW 2MM X 13MM |
| Product Code | EEA |
| Date Received | 1993-08-01 |
| ID Number | 01-9413 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | * |
| Implant Flag | Y |
| Date Removed | V |
| Device Sequence No | 1 |
| Device Event Key | 10317 |
| Manufacturer | WALTER LORENZ SURGICAL INST. CO. |
| Manufacturer Address | 1520 TRADEPOST DR. JACKSONVILLE FL 322182480 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 1993-08-01 |