MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-05-04 for UNKNOWN_FRO_PRODUCT UNK_FRO manufactured by Stryker Orthopaedics-limerick.
[107589563]
Device is not available for evaluation. If additional information is received it will be reported on a supplemental report. Device not available for return.
Patient Sequence No: 1, Text Type: N, H10
[107589564]
It was reported that hydroset was used on the margins of a craniotomy (including the drill hole). After a revision surgery for another reason, it was found that the material was crumbly, detached from the gap and the drill hole, and had not persisted as a solid matrix. The material was removed but not replaced by another hydroset. There were no adverse consequences to the patient due to the use of the bone cement.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0008010177-2018-00038 |
| MDR Report Key | 7487764 |
| Date Received | 2018-05-04 |
| Date of Report | 2018-05-04 |
| Date of Event | 2018-03-29 |
| Date Mfgr Received | 2018-04-06 |
| Date Added to Maude | 2018-05-04 |
| 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 | 3 |
| Manufacturer Contact | MR. KELLI DYKSTRA |
| Manufacturer Street | BOETZINGERSTR. 41 |
| Manufacturer City | FREIBURG D-79111 |
| Manufacturer Postal | D-79111 |
| Manufacturer Phone | 76145120 |
| Manufacturer G1 | STRYKER ORTHOPAEDICS-LIMERICK |
| Manufacturer Street | RAHEEN BUSINESS PARK |
| Manufacturer City | LIMERICK NA |
| Manufacturer Postal Code | NA |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | UNKNOWN_FRO_PRODUCT |
| Generic Name | IMPLANT |
| Product Code | GXP |
| Date Received | 2018-05-04 |
| Catalog Number | UNK_FRO |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STRYKER ORTHOPAEDICS-LIMERICK |
| Manufacturer Address | RAHEEN BUSINESS PARK LIMERICK NA NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-05-04 |