MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,07 report with the FDA on 2010-02-16 for OSTEONICS SIZED CEMENT-PLUG B004-0155 manufactured by Stryker Orthopaedics Mahwah.
[1423724]
It was reported that, "when the surgeon opened the sterilization pack, the plug already has dissociated from the plastic sheet. "
Patient Sequence No: 1, Text Type: D, B5
[8444690]
An evaluation of the device cannot be performed as the device was implanted in the pt and was not returned to the manufacturer. Additional information pertaining to the device referenced in this report was requested. If it becomes available, the evaluation summary will be submitted in a supplemental report.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2249697-2010-00163 |
| MDR Report Key | 1610913 |
| Report Source | 01,07 |
| Date Received | 2010-02-16 |
| Date of Report | 2010-01-15 |
| Date of Event | 2010-01-15 |
| Date Mfgr Received | 2010-01-15 |
| Date Added to Maude | 2010-10-12 |
| 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 | JADWIGA DEGRADO |
| Manufacturer Street | 325 CORPORATE DR. |
| Manufacturer City | MAHWAH NJ 07430 |
| Manufacturer Country | US |
| Manufacturer Postal | 07430 |
| Manufacturer Phone | 2018315000 |
| Manufacturer G1 | STRYKER ORTHOPAEDICS |
| 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 | OSTEONICS SIZED CEMENT-PLUG |
| Generic Name | IMPLANT |
| Product Code | LTO |
| Date Received | 2010-02-16 |
| Model Number | NA |
| Catalog Number | B004-0155 |
| Lot Number | UNK |
| 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 | 2010-02-16 |