MAUDE Adverse Event Report: STRYKER GMBH UNKNOWN LEIBINGER LOW PROFILE TITANIUM PLATE; IMPLANT

Catalog Number UNK_SEL

Device Problems Mechanical Problem (1384); Physical Resistance/Sticking (4012)

Patient Problem Limited Mobility Of The Implanted Joint (2671)

Event Date 01/01/1996

Event Type  Injury  

Manufacturer Narrative

Device will not be returned.If additional information becomes available, it will be provided in a supplemental report.Device disposition unknown.

Event Description

The manufacturer became aware of a literature from (b)(6) hospital, (b)(6).The title of this report is ¿low-profile plate fixation in arthrodesis of the first metacarpophalangeal joint¿ which was published in february 2011 and is associated with the stryker variax hand plating system.Within that publication, post-operative complications/ adverse events were reported, which occurred between 1996 to 2003.It was not possible to ascertain specific device and/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 7 complaints were initiated retrospectively for different adverse events mentioned in the journal.This product inquiry addresses restricted movement of the ip joint.The study states that ¿another patient required a tenolysis, because of restricted movement of the ip joint which improved motion.¿.

• Brand Name: UNKNOWN LEIBINGER LOW PROFILE TITANIUM PLATE
• Type of Device: IMPLANT
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• Manufacturer (Section G): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• Manufacturer Contact: kevin smith ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 8743877
• MDR Text Key: 149494705
• Report Number: 0008031020-2019-00758
• Device Sequence Number: 1
• Product Code: JEY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: UNK_SEL
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/10/2019
• 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): Required Intervention