MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-01-03 for 5CC HYDROSET INJECTABLE CEMENT 79-43905 manufactured by Stryker Orthopaedics-limerick.
[96329829]
Device is not available for evaluation. If additional information is received it will be reported on a supplemental report. Please note, actual quantity of devices reported is two. Discarded at facility.
Patient Sequence No: 1, Text Type: N, H10
[96329830]
It was reported by the company representative that during the procedure, the physician stated that the product was cracking when placed in patient. The procedure was completed sucessfully. On (b)(6) 2017 the physician had to re-visit the same patient and noticied that the product was not in place. Another hydroset was then utilized, and the physician reported that it was cracking again when placing in the patient. This procedure was completed succesfully as well. The sales rep was not present during these procedures.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0008010177-2018-00002 |
| MDR Report Key | 7160142 |
| Date Received | 2018-01-03 |
| Date of Report | 2018-01-03 |
| Date of Event | 2017-11-29 |
| Date Mfgr Received | 2017-12-08 |
| Date Added to Maude | 2018-01-03 |
| 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 | 2018-01-03 |
| Catalog Number | 79-43905 |
| Lot Number | V85SGIC02484 |
| 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 | 1. Required No Informationntervention | 2018-01-03 |