MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-01-21 for UNKNOWN STRYKER ELBOW UNK_JR manufactured by Stryker Orthopaedics-mahwah.
[133701114]
It was noted that the device is not available for evaluation. If additional information is received, it will be provided in a supplemental report upon completion of the investigation.
Patient Sequence No: 1, Text Type: N, H10
[133701115]
Patient called stating she had an elbow surgery done on (b)(6) 2017. Patient stated the screws came out and she is scheduled for a revision on (b)(6) 2019.
Patient Sequence No: 1, Text Type: D, B5
Report Number | 0002249697-2019-00232 |
MDR Report Key | 8264409 |
Date Received | 2019-01-21 |
Date of Report | 2019-01-21 |
Date of Event | 2017-09-15 |
Date Mfgr Received | 2018-12-26 |
Date Added to Maude | 2019-01-21 |
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. BRAD CURTIS |
Manufacturer Street | 325 CORPORATE DRIVE |
Manufacturer City | MAHWAH NJ 07430 |
Manufacturer Country | US |
Manufacturer Postal | 07430 |
Manufacturer Phone | 2018315000 |
Manufacturer G1 | STRYKER ORTHOPAEDICS-MAHWAH |
Manufacturer Street | 325 CORPORATE DRIVE |
Manufacturer City | MAHWAH NJ 07430 |
Manufacturer Country | US |
Manufacturer Postal Code | 07430 |
Single Use | 3 |
Previous Use Code | 3 |
Event Type | 3 |
Type of Report | 0 |
Brand Name | UNKNOWN STRYKER ELBOW |
Generic Name | ELBOW IMPLANT |
Product Code | JDB |
Date Received | 2019-01-21 |
Catalog Number | UNK_JR |
Lot Number | UNK |
Operator | HEALTH PROFESSIONAL |
Device Availability | N |
Device Eval'ed by Mfgr | R |
Device Sequence No | 1 |
Device Event Key | 0 |
Manufacturer | STRYKER ORTHOPAEDICS-MAHWAH |
Manufacturer Address | 325 CORPORATE DRIVE MAHWAH NJ 07430 US 07430 |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 1. Other | 2019-01-21 |