MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-12-22 for RECON ULNAR STEM IMPLANT #3, 20MM EXTENSION UHAS320 manufactured by Stryker Gmbh.
[34883558]
With guidance from the mdr policy branch of the fda, mdr reported by stryker (b)(4) as a result of a retrospective lookback of complaints resulting from the acquisition of assets from (b)(4). Device will not be returned. If additional information becomes available it will be provided on a supplemental report. The reported device was manufactured and distributed by (b)(4) and implanted prior to howmedica osteonics corp.? S purchase of certain assets of (b)(4) on august 1, 2014. Stryker became legal manufacturer of this product on april 1, 2015 and has taken the responsibility for medical device reporting. Device is not available to stryker.
Patient Sequence No: 1, Text Type: N, H10
[34883559]
Implant breaking through packaging (rnc 3425) - (b)(4) is currently conducting a recovery of packaged product associated with the packaging breach. This activity will repackage (b)(4) product with a (2) year expiration date. Concurrently a new package design is under validation
Patient Sequence No: 1, Text Type: D, B5
[38294155]
Patient Sequence No: 1, Text Type: N, H10
[38294156]
Implant breaking through packaging ((b)(4)) - sbi is currently conducting a recovery of packaged product associated with the packaging breach. This activity will repackage sbi product with a (2) year expiration date. Concurrently a new package design is under validation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0008031020-2015-00603 |
| MDR Report Key | 5319938 |
| Date Received | 2015-12-22 |
| Date of Report | 2013-07-17 |
| Date of Event | 2013-07-17 |
| Date Mfgr Received | 2016-02-16 |
| Device Manufacturer Date | 2008-08-01 |
| Date Added to Maude | 2015-12-22 |
| 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. ROSE HAAS |
| 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 | 3 |
| Brand Name | RECON ULNAR STEM IMPLANT #3, 20MM EXTENSION |
| Generic Name | PROSTHESIS, WRIST, HEMI-, ULNAR |
| Product Code | KXE |
| Date Received | 2015-12-22 |
| Catalog Number | UHAS320 |
| Lot Number | 12214 |
| Device Expiration Date | 2013-07-31 |
| 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 GMBH |
| Manufacturer Address | BOHNACKERWEG 1 POSTFACH SELZACH 2545 CH 2545 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2015-12-22 |