MAUDE Adverse Event Report: STRYKER GMBH UNKNOWN TENXOR PIN; IMPLANT

Catalog Number UNK_SEL

Device Problem Insufficient Information (3190)

Patient Problems Unspecified Infection (1930); Patient Problem/Medical Problem (2688)

Event Date 09/19/2006

Event Type  Injury  

Manufacturer Narrative

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.

Event Description

The manufacturer became aware of a national post-market product surveillance from hospital (b)(6).The title of this report is ¿national post-market product surveillance - tenxor external fixation system¿ which was issued on 9/19/2006 and is associated with the tenxor external fixation system.Within that report, postoperative complications/ adverse events were reported.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 author of the publication, therefore 11 complaints were initiated retrospectively for different adverse events mentioned in the report.This product inquiry addresses infection.One out of 6.The post-market product surveillance states: ¿at the six months assessment, one patient showed a rotational deformity of the foot after the treatment of his distal tibia fracture.The tenxor¿ system was removed and the patient was treated with an ankle arthrodesis [pat.No.2].¿.

• Brand Name: UNKNOWN TENXOR PIN
• Type of Device: IMPLANT
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• Manufacturer (Section G): STRYKER LEIBINGER FREIBURG; boetzingerstr. 41; freiburg D-791 11
• Manufacturer Contact: rose haas ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 7907624
• MDR Text Key: 121705071
• Report Number: 0008031020-2018-00635
• Device Sequence Number: 1
• Product Code: KTT
• Combination Product (y/n): N
• Reporter Country Code: ES
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/25/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: UNK_SEL
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/02/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other