MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2006-05-22 for UNIPLATE ACP LARGE BONE SCREW, 5.20X14MM 189706114 manufactured by Depuy Spine, Inc..
[18918268]
Contact reported that 3 weeks post-op, center screw of a two level cervical plate had backed out approx. 3mm. Surgeon performed a revision to remove the screw.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1526439-2006-00112 |
| MDR Report Key | 717450 |
| Date Received | 2006-05-22 |
| Date Mfgr Received | 2006-05-11 |
| Date Added to Maude | 2006-05-24 |
| 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 | MATHEW KING |
| Manufacturer Street | 325 PARAMOUNT DRIVE |
| Manufacturer City | RAYNHAM MA 02767 |
| Manufacturer Country | US |
| Manufacturer Postal | 02767 |
| Manufacturer Phone | 5088283106 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UNIPLATE ACP LARGE BONE SCREW, 5.20X14MM |
| Generic Name | BONE SCREW |
| Product Code | JBS |
| Date Received | 2006-05-22 |
| Model Number | NA |
| Catalog Number | 189706114 |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | Y |
| Date Removed | V |
| Device Sequence No | 1 |
| Device Event Key | 706514 |
| Manufacturer | DEPUY SPINE, INC. |
| Manufacturer Address | 325 PARAMOUNT DR. RAYNHAM MA 02767 US |
| Baseline Brand Name | UNIPLATE ACP LARGE BONE SCREW, 5.20X14MM |
| Baseline Generic Name | BONE SCREW |
| Baseline Model No | NA |
| Baseline Catalog No | 189706114 |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2006-05-22 |