MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2006-10-25 for ACCOLADE CALCAR PLANNER 1020-2700 manufactured by Stryker Orthopaedics Mahwah.
[519007]
It was reported "surgeon implanted a 52mm trident psl cup with a 36mm 0 degree crossfire insert. Axial reamed and then broached the femur to a pressfit #9 using the cutting edge advantage gold instruments. Placed the 1020-2700 calcar planer on a power reamer in the usual fashion and placed the planer on the peg trunion of the inserted broach. During the planing process, a large piece of calcar bone was broken away. Requiring the use of an inhouse 1. 7mm synthes cocr orthopaedic cable to repair. "
Patient Sequence No: 1, Text Type: D, B5
[7917203]
Device not returned. No evaluation will be performed. If device becomes available a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2249697-2006-00127 |
| MDR Report Key | 774422 |
| Report Source | 07 |
| Date Received | 2006-10-25 |
| Date of Report | 2006-10-02 |
| Date of Event | 2006-10-02 |
| Date Mfgr Received | 2006-10-02 |
| Date Added to Maude | 2006-10-31 |
| 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 | ROSE MINCIELI |
| Manufacturer Street | 325 CORPORATE DRIVE |
| Manufacturer City | MAHWAH NJ 07430 |
| Manufacturer Country | US |
| Manufacturer Postal | 07430 |
| Manufacturer Phone | 1201831500 |
| Manufacturer G1 | STRYKER ORTHOPAEDICS MAHWAH |
| Manufacturer Street | 325 CORPORATE DRIVE |
| Manufacturer City | MAHWAH NJ 07430 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 07430 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ACCOLADE CALCAR PLANNER |
| Generic Name | INSTRUMENT |
| Product Code | KHY |
| Date Received | 2006-10-25 |
| Model Number | NA |
| Catalog Number | 1020-2700 |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Implant Flag | Y |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 762203 |
| Manufacturer | STRYKER ORTHOPAEDICS MAHWAH |
| Manufacturer Address | * MAHWAH NJ 07430 US |
| Baseline Brand Name | ACCOLADE CALCAR PLANNER |
| Baseline Generic Name | INSTRUMENT |
| Baseline Model No | NA |
| Baseline Catalog No | 1020-2700 |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2006-10-25 |