MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2013-06-19 for PIN TO ROD COUPLING HOFFMANN II COMPACT 5/3-4MM 49401020 manufactured by Stryker Osteosynthesis-selzach.
[3467154]
It was reported that the patient came in on (b)(6) 2013 with pin to rod clamp loosening. Surgeon removed device and patient was revised to cast due to patient non conformance with aftercare. Doctor disposed of part after being taken out during regular clinical checkup.
Patient Sequence No: 1, Text Type: D, B5
[10754107]
Device was discarded. If additional information was received it will be reported on a supplemental report.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 0008031020-2013-00193 |
| MDR Report Key | 3176365 |
| Report Source | 05 |
| Date Received | 2013-06-19 |
| Date of Report | 2013-06-03 |
| Date of Event | 2013-05-20 |
| Date Mfgr Received | 2013-06-03 |
| Date Added to Maude | 2013-06-19 |
| 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 | MR. ROSE MINCIELI |
| Manufacturer Street | 325 CORPORATE DRIVE |
| Manufacturer City | MAHWAH NJ 07430 |
| Manufacturer Country | US |
| Manufacturer Postal | 07430 |
| Manufacturer Phone | 2018315000 |
| Manufacturer G1 | STRYKER OSTEOSYNTHESIS-SELZACH |
| Manufacturer Street | BOHNACKERWEG 1 POSTFACH |
| Manufacturer City | SELZACH 2545 |
| Manufacturer Country | CH |
| Manufacturer Postal Code | 2545 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PIN TO ROD COUPLING HOFFMANN II COMPACT 5/3-4MM |
| Generic Name | IMPLANT |
| Product Code | JEC |
| Date Received | 2013-06-19 |
| Catalog Number | 49401020 |
| Lot Number | UNKNOWN |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STRYKER OSTEOSYNTHESIS-SELZACH |
| Manufacturer Address | BOHNACKERWEG 1 POSTFACH SELZACH 2545 CH 2545 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2013-06-19 |