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

Catalog Number UNK_SEL

Device Problem Migration (4003)

Patient Problem Failure of Implant (1924)

Event Date 08/11/2016

Event Type  Injury  

Event Description

The manufacturer became aware of a literature published by the ¿university hospital southampton nhs foundation trust, uk ¿.The title of this report is ¿operative treatment of calcaneal fractures: improved outcomes and low complications rates with a strict management protocol ¿, published on august 11, 2016, and can be found at doi 10.1308/rcsann.2016.0259.The report is associated with the stryker ¿sps small fragment plating system¿ and includes an analysis of the clinical data that was collected on 80 patients.The cases in this range from 2005 and 2014.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 screw prominence in the subtalar joint, which required a repeat procedure.

Manufacturer Narrative

This complaint has been generated based on findings identified during post market surveillance literature review published by the ¿university hospital southampton nhs foundation trust, uk ¿.The article can be found at doi 10.1308/rcsann.2016.0259.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 SPS CALCANEAL 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: 15673629
• MDR Text Key: 302421834
• Report Number: 0008031020-2022-00562
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 10/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2022
• 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
• Date Manufacturer Received: 09/30/2022
• 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