MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-04-18 for UNKNOWN HOFFMAN XPRESS UNK_SEL manufactured by Stryker Gmbh.
[142469080]
Device will not be returned. If additional information becomes available it will be provided on a supplemental report. Device evaluated by mfr: device disposition unknown.
Patient Sequence No: 1, Text Type: N, H10
[142469081]
The manufacturer became aware of a study from hannover medical school, hannover, germany. The title of this study is? Surgical management of charcot deformity for the foot and ankle - radiologic outcome after internal/external fixation? And is associated with the stryker hoffmann xpress external fixation system. Within that publication, post-operative complications/ adverse events were reported, which occurred between june 2010 to march 2015. It was not possible to ascertain specific device catalogs from the report; a review of the complaint handling database, however, revealed that the events have not been reported by the hospital or by the author of the publication. Therefore, 2 complaints were initiated retrospectively for different adverse events mentioned in the report. This product inquiry addresses deep infection and non-union. The patient underwent revision and ultimately required transtibial amputation after tc or ttc arthrodesis using external fixation because of persistent infection. 1 out of 2 cases.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0008031020-2019-00362 |
| MDR Report Key | 8527697 |
| Date Received | 2019-04-18 |
| Date of Report | 2019-04-18 |
| Date of Event | 2010-06-01 |
| Date Mfgr Received | 2019-04-08 |
| Date Added to Maude | 2019-04-18 |
| 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 | 0 |
| Brand Name | UNKNOWN HOFFMAN XPRESS |
| Generic Name | IMPLANT |
| Product Code | LXT |
| Date Received | 2019-04-18 |
| 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 | 2019-04-18 |