MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2009-10-19 for BIO-PREP BONE PREPARATION KIT 0206710000 manufactured by Stryker Instruments Puerto Rico.
[1120774]
It was reported that the bone plug inserter broke off inside the pt's femoral canal. It is unk if the pieces were retrieved or if the pt required add'l treatment.
Patient Sequence No: 1, Text Type: D, B5
[8364970]
The device was not returned to the mfr for investigation. No add'l info was received by the facility despite numerous attempts.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2648666-2009-00247 |
| MDR Report Key | 1517307 |
| Report Source | 07 |
| Date Received | 2009-10-19 |
| Date of Report | 2009-09-22 |
| Date of Event | 2009-09-22 |
| Date Mfgr Received | 2009-09-22 |
| Date Added to Maude | 2009-10-30 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | CHRISTINA MCKEE |
| Manufacturer Street | 4100 E. MILHAM AVE. |
| Manufacturer City | KALAMAZOO MI 49001 |
| Manufacturer Country | US |
| Manufacturer Postal | 49001 |
| Manufacturer Phone | 2693237700 |
| Manufacturer G1 | STRYKER INSTRUMENTS PUERTO RICO |
| Manufacturer Street | PO BOX 329 |
| Manufacturer City | ARROYO PR 00714 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 00714 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BIO-PREP BONE PREPARATION KIT |
| Generic Name | PROTHESIS, HIP, CEMENT RESTRICTOR |
| Product Code | JDK |
| Date Received | 2009-10-19 |
| Catalog Number | 0206710000 |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STRYKER INSTRUMENTS PUERTO RICO |
| Manufacturer Address | ARROYO PR 00714 US 00714 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2009-10-19 |