MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2003-11-20 for CARROL-GIRARD SCREW * 01-0265 manufactured by W. Lorenz Surgical, Inc..
[296370]
Zygomatic arch was fractured, inserted screw, while pulling it out, it broke. Unable to remove small fragment of instrument.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1032347-2003-00015 |
| MDR Report Key | 497912 |
| Report Source | 06 |
| Date Received | 2003-11-20 |
| Date of Report | 2003-10-21 |
| Date of Event | 2003-10-21 |
| Date Mfgr Received | 2003-10-21 |
| Device Manufacturer Date | 2002-11-01 |
| Date Added to Maude | 2003-12-01 |
| 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 | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | CHRISTY ROBERTS |
| Manufacturer Street | 1520 TRADEPORT DRIVE |
| Manufacturer City | JACKSONVILLE FL 32218 |
| Manufacturer Country | US |
| Manufacturer Postal | 32218 |
| Manufacturer Phone | 9047419468 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CARROL-GIRARD SCREW |
| Generic Name | GENERAL INSTRUMENTATION |
| Product Code | GEG |
| Date Received | 2003-11-20 |
| Model Number | * |
| Catalog Number | 01-0265 |
| Lot Number | 318080 |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | Y |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 486659 |
| Manufacturer | W. LORENZ SURGICAL, INC. |
| Manufacturer Address | 1520 TRADEPORT DR. JACKSONVILLE FL 32218 US |
| Baseline Brand Name | CARROL-GIRARD SCREW |
| Baseline Generic Name | ZYGOMA ELEVATOR |
| Baseline Model No | NA |
| Baseline Catalog No | 01-0265 |
| Baseline ID | NA |
| Baseline Device Family | GENERAL INSTRUMENTATION |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | N |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2003-11-20 |