MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-05-07 for UNKNOWN SBI RADIAL HEAD UNK_SEL manufactured by Stryker Gmbh.
[144399394]
Device was not returned. If additional information becomes available, it will be provided in a supplemental report. Device disposition unknown.
Patient Sequence No: 1, Text Type: N, H10
[144399395]
Rep was notified that the surgeon will be performing a revision on (b)(6) 2019 of a radial head device.
Patient Sequence No: 1, Text Type: D, B5
Report Number | 0008031020-2019-00398 |
MDR Report Key | 8588614 |
Date Received | 2019-05-07 |
Date of Report | 2019-05-07 |
Date of Event | 2019-04-17 |
Date Mfgr Received | 2019-04-17 |
Date Added to Maude | 2019-05-07 |
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. KEVIN SMITH |
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 SBI RADIAL HEAD |
Generic Name | IMPLANT |
Product Code | JDB |
Date Received | 2019-05-07 |
Catalog Number | UNK_SEL |
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 GMBH |
Manufacturer Address | BOHNACKERWEG 1 POSTFACH SELZACH 2545 CH 2545 |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 1. Required No Informationntervention | 2019-05-07 |