MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2005-06-21 for RELIANCE TEARDROP CURETTE ANGLED 48361630 manufactured by Stryker Spine Bordeaux.
[516944]
It was reported "surgeon was using teardrop curette to prepare disc space for tlif graft. As he continued clearing disc, the teardrop portion of the instrument broke off into the disc space. It was necessary for the surgeon to take additional time in order to "fish" the broken metal out of the pt's disc space. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9617544-2005-00043 |
| MDR Report Key | 744990 |
| Report Source | 07 |
| Date Received | 2005-06-21 |
| Date of Report | 2005-05-25 |
| Date of Event | 2005-05-25 |
| Date Mfgr Received | 2005-05-25 |
| Device Manufacturer Date | 2004-10-01 |
| Date Added to Maude | 2006-08-09 |
| 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 | JANICE PEVIDE |
| Manufacturer Street | 325 CORPORATE DR |
| Manufacturer City | MAHWAH NJ 07430 |
| Manufacturer Country | US |
| Manufacturer Postal | 07430 |
| Manufacturer Phone | 2018315000 |
| Manufacturer G1 | STRYKER SPINE BORDEAUX |
| Manufacturer Street | ZONE INDUSTRIELLE DE MARTICOT |
| Manufacturer City | CESTAS 33610 |
| Manufacturer Country | FR |
| Manufacturer Postal Code | 33610 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RELIANCE TEARDROP CURETTE ANGLED |
| Generic Name | INSTRUMENT |
| Product Code | FZS |
| Date Received | 2005-06-21 |
| Model Number | NA |
| Catalog Number | 48361630 |
| Lot Number | 047233 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 732778 |
| Manufacturer | STRYKER SPINE BORDEAUX |
| Manufacturer Address | * CESTAS FR 33610 |
| Baseline Brand Name | RELIANCE TEARDROP CURETTE ANGLED |
| Baseline Generic Name | INSTRUMENT |
| Baseline Model No | NA |
| Baseline Catalog No | 48361630 |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2005-06-21 |