MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-05-09 for UNKNOWN MCP SILICONE JOINT UNK_SEL manufactured by Stryker Gmbh.
[74933161]
Once the investigation has been completed any additional information will be reported in a supplemental report.
Patient Sequence No: 1, Text Type: N, H10
[74933162]
Sales rep reported patient presented with fracture to mcp joint. Dr related fracture to the implant. Upon removal of the silicone implant it was found broken into two pieces. The surgical site was cleaned up and a new mcpx-20 preflexed implant was inserted into the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0008031020-2017-00289 |
| MDR Report Key | 6554415 |
| Date Received | 2017-05-09 |
| Date of Report | 2017-10-26 |
| Date of Event | 2017-04-11 |
| Date Mfgr Received | 2017-10-05 |
| Date Added to Maude | 2017-05-09 |
| 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. ANNA JUSINSKI |
| Manufacturer Street | 325 CORPORATE DRIVE |
| Manufacturer City | MAHWAH NJ 07430 |
| Manufacturer Country | US |
| Manufacturer Postal | 07430 |
| Manufacturer Phone | 2018315000 |
| Manufacturer G1 | STRYKER GMBH |
| 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 | 0 |
| Brand Name | UNKNOWN MCP SILICONE JOINT |
| Generic Name | IMPLANT |
| Product Code | NEG |
| Date Received | 2017-05-09 |
| Catalog Number | UNK_SEL |
| Lot Number | UNKNOWN |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STRYKER GMBH |
| Manufacturer Address | BOHNACKERWEG 1 POSTFACH SELZACH 2545 CH 2545 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2017-05-09 |