MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a literature report with the FDA on 2018-10-15 for LOW-PROFILE TITANIUM MINI-PLATING SYSTEM UNK_SEL manufactured by Stryker Gmbh.
[123750222]
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. Device disposition is unknown.
Patient Sequence No: 1, Text Type: N, H10
[123750223]
The manufacturer became aware of a study from st james? S university hospital, leeds, uk. The title of this study is? The role of low-profile titanium miniplates in emergency and elective hand surgery? , which was published in june 1999 and is associated with? Leibinger low profile titanium mini-plating system?. Within that publication, post-operative complications/ adverse events were reported, which occurred between february 1994 to february 1997. It was not possible to ascertain specific device or patient information from the article; a review of the complaint handling database, however, revealed that the events have not been reported by the hospital or by the authors of the publication. Therefore, 25 complaints were initiated retrospectively for different adverse events mentioned in the study. This product inquiry addresses reduced range of movement. 9 out of 11 cases.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0008031020-2018-00790 |
| MDR Report Key | 7966724 |
| Report Source | LITERATURE |
| Date Received | 2018-10-15 |
| Date of Report | 2018-10-15 |
| Date of Event | 2018-09-14 |
| Date Mfgr Received | 2018-09-18 |
| Date Added to Maude | 2018-10-15 |
| 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 LEIBINGER FREIBURG |
| Manufacturer Street | BOETZINGERSTR. 41 |
| Manufacturer City | FREIBURG D-79111 |
| Manufacturer Postal Code | D-79111 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LOW-PROFILE TITANIUM MINI-PLATING SYSTEM |
| Generic Name | IMPLANT |
| Product Code | GWO |
| Date Received | 2018-10-15 |
| Catalog Number | UNK_SEL |
| 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. Other | 2018-10-15 |