MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2008-11-24 for RV. UNIVERSAL CEMENT RESTRICTOR B000-0300 manufactured by Stryker Orthopaedics Mahwah.
[16715069]
It was reported that "cement restrictors are brittle and stiff and when put down the canal they break".
Patient Sequence No: 1, Text Type: D, B5
[16981928]
An evaluation of the device cannot be performed as the device was not returned to the manufacturer. Device broken, bloody and discarded, and therefore, it is not available for evaluation. Additional information has been requested. Should device become available, the evaluation summary will be submitted in a supplemental report.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2249697-2008-00373 |
| MDR Report Key | 1244483 |
| Report Source | 07 |
| Date Received | 2008-11-24 |
| Date of Report | 2008-10-30 |
| Date of Event | 2008-10-30 |
| Date Mfgr Received | 2008-10-30 |
| Date Added to Maude | 2009-11-10 |
| 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 | NKEIRU GREEN |
| Manufacturer Street | 325 CORPORATE DR. |
| Manufacturer City | MAHWAH NJ 07430 |
| Manufacturer Country | US |
| Manufacturer Postal | 07430 |
| Manufacturer Phone | 2018315000 |
| Manufacturer G1 | STRYKER ORTHOPAEDICS MAHWAH |
| Manufacturer Street | 325 CORPORATE DR. |
| Manufacturer City | MAHWAH NJ 07430 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 07430 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RV. UNIVERSAL CEMENT RESTRICTOR |
| Generic Name | IMPLANT |
| Product Code | JDK |
| Date Received | 2008-11-24 |
| Model Number | NA |
| Catalog Number | B000-0300 |
| Lot Number | 6M7496 |
| ID 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 ORTHOPAEDICS MAHWAH |
| Manufacturer Address | MAHWAH NJ 07430 US 07430 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2008-11-24 |