MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-07-07 for 5CC HYDROSET INJECTABLE CEMENT 79-43905 manufactured by Stryker Orthopaedics-limerick.
[79630184]
Device is not available for evaluation. If additional information is received it will be reported on a supplemental report. Device still implanted in patient.
Patient Sequence No: 1, Text Type: N, H10
[79630185]
It was reported that the parents of a patient requested advice from a surgeon who had used the hydroset device 1 year ago in their (b)(6) child to close a cranium defect - they are worried that the bone could grow into the cement, as the patient's head is not fully developed. No adverse consequences nor medical intervention were reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0008010177-2017-00163 |
| MDR Report Key | 6695671 |
| Date Received | 2017-07-07 |
| Date of Report | 2017-11-02 |
| Date of Event | 2017-06-08 |
| Date Mfgr Received | 2017-06-08 |
| Date Added to Maude | 2017-07-07 |
| 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 | 5CC HYDROSET INJECTABLE CEMENT |
| Generic Name | IMPLANT |
| Product Code | GXP |
| Date Received | 2017-07-07 |
| Catalog Number | 79-43905 |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| 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 | 2017-07-07 |