MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2018-02-16 for UNKNOWN_FRO_PRODUCT UNK_FRO manufactured by Stryker Orthopaedics-limerick.
[100305032]
The device is not available for evaluation. If additional information is received, it will be reported on a supplemental report. Source of information was a retrospective study involving patients treated between (b)(6) 2012 and 2015, so reasonable expectation is all explanted material was discarded.
Patient Sequence No: 1, Text Type: N, H10
[100305033]
It was noted through a medical journal that 11 patients contracted an infection requiring revision for removal of all or some of an unknown hydroset osteosynthesis material. The original procedure was completed successfully without a delay. There is no other information available regarding the event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0008010177-2018-00013 |
| MDR Report Key | 7277729 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2018-02-16 |
| Date of Report | 2018-04-23 |
| Date of Event | 2016-05-25 |
| Date Mfgr Received | 2018-01-18 |
| Date Added to Maude | 2018-02-16 |
| 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. GREGORY GOHL |
| 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 | 3 |
| Brand Name | UNKNOWN_FRO_PRODUCT |
| Generic Name | IMPLANT |
| Product Code | GXP |
| Date Received | 2018-02-16 |
| Catalog Number | UNK_FRO |
| 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-LIMERICK |
| Manufacturer Address | RAHEEN BUSINESS PARK LIMERICK NA NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-02-16 |