MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2006-02-22 for INCOMPASS CLOSURE TOP T-HANDLE 2151-4 manufactured by Abbott Spine.
[403323]
Upon reviewing a follow up x-ray, the surgeon noted that the sheared off portion of the closure top was left within the patient. The device for implanting closure tops did not hold the sheared portion as intended and the sheared portion fell into the wound and was not retrieved.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1649384-2006-00014 |
| MDR Report Key | 680418 |
| Report Source | 07 |
| Date Received | 2006-02-22 |
| Date of Report | 2006-02-20 |
| Date of Event | 2006-01-16 |
| Date Mfgr Received | 2006-02-02 |
| Date Added to Maude | 2006-03-02 |
| 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 | ANDREA MCGUIRE-GROVNER, SR. ANAL |
| Manufacturer Street | 5301 RIATA PARK COURT, BLDG. F |
| Manufacturer City | AUSTIN TX 78727 |
| Manufacturer Country | US |
| Manufacturer Postal | 78727 |
| Manufacturer Phone | 5125331884 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | INCOMPASS CLOSURE TOP T-HANDLE |
| Generic Name | QUICK RELEASE T-HANDLE |
| Product Code | MCY |
| Date Received | 2006-02-22 |
| Model Number | NA |
| Catalog Number | 2151-4 |
| Lot Number | NI |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 669682 |
| Manufacturer | ABBOTT SPINE |
| Manufacturer Address | * AUSTIN TX * US |
| Baseline Brand Name | INCOMPASS CLOSURE TOP T-HANDLE |
| Baseline Generic Name | QUICH RELEASE T-HANDLE |
| Baseline Model No | NA |
| Baseline Catalog No | 2151-4 |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2006-02-22 |