MAUDE Adverse Event Report: STRYKER GMBH UNKNOWN VARIAX CALCANEAL MESH PLATE; PLATE, FIXATION, BONE

Catalog Number UNK_SEL

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

Patient Problem Post Operative Wound Infection (2446)

Event Date 03/01/2014

Event Type  Injury  

Event Description

The manufacturer became aware of a literature published by the ¿department of orthopaedic surgery, yokkaichi municipal hospital, japan¿.The title of this report is ¿treatment for comminuted intraarticular fractures of the lower legs using variax calcaneus mesh plate¿, published on march 01, 2014, and can be found at https://doi.Org/10.11359/chubu.2014.425.The report is associated with the stryker ¿variax foot locking plate system¿ and includes an analysis of the clinical data that was collected on 7 patients.The cases in this study range from march 2011 to august 2013.During the review of the literature, it was not possible to establish a precise device(s) identification or patient information; however, the article alleges that 1 patient experienced wound infection 3 months after surgery, but infection subsided after plate removal and administration of antimicrobials.

Manufacturer Narrative

This complaint has been generated based on findings identified during post market surveillance literature review published by the ¿department of orthopaedic surgery, yokkaichi municipal hospital, japan¿.The article can be found at https://doi.Org/10.11359/chubu.2014.425.  the reported event could not be confirmed since the device was not returned for evaluation and no other additional information was received from the author.  more detailed information about the patient's medical history, the event details and the involved device(s) must be available to determine the root cause.   if any additional information becomes available, the investigation will be reopened and re-evaluated accordingly.

• Brand Name: UNKNOWN VARIAX CALCANEAL MESH PLATE
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer (Section G): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 15546385
• MDR Text Key: 301236730
• Report Number: 0008031020-2022-00502
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/05/2022

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?: 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
• Initial Date Manufacturer Received: 09/12/2022
• Initial Date FDA Received: 10/05/2022
• 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