MAUDE Adverse Event Report: STRYKER GMBH UNKNOWN VARIAX ELBOW PLATE; IMPLANT

Catalog Number UNK_SEL

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Irritation (1941)

Event Date 01/01/2012

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 post market clinical follow-up (pmcf) from (b)(6) medical center.The title of this report is ¿a post market clinical follow-up (pmcf) of the treatment of elbow fractures with the stryker variax elbow plate system¿ which was published in april 2019 and is associated with stryker variax elbow plate system.Within that publication, post-operative complications/ adverse events were reported, which occurred between 2012 and 2018.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 8 complaints were initiated retrospectively for different adverse events mentioned in the report.This product inquiry addresses hardware irritation.1 out of 2 cases.The study states: ¿the first and the second patient developed hardware irritation.The first patient had their distal locking screws lose purchase in the plate and back out.No hardware had to be removed.Both patients went on to consolidation.¿.

• Brand Name: UNKNOWN VARIAX ELBOW 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: rose haas ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 8703665
• MDR Text Key: 148167140
• Report Number: 0008031020-2019-00558
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 06/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• 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
• Initial Date Manufacturer Received: 05/22/2019
• Initial Date FDA Received: 06/17/2019
• 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): Other