MAUDE Adverse Event Report: STRYKER GMBH UNKNOWN PRO 3D ANATOMICAL-PRESHAPED SUPRAPECTINEAL PLATE; PLATE, FIXATION, BONE

Catalog Number UNK_SEL

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

Patient Problem Unspecified Infection (1930)

Event Date 07/01/2017

Event Type  Injury  

Event Description

The manufacturer became aware of a literature published by the ¿department of trauma-, hand- and reconstructive surgery, university hospital jena, germany¿.The title of this report is "the anterior intrapelvic approach for acetabular fractures using approach-specific instruments and an anatomical-preshaped 3-dimensional suprapectineal plate", published on july 01, 2017, and can be found at doi: 10.1097/bot.0000000000000829.The report is associated with the stryker 'pro plating system' and includes an analysis of the clinical data that was collected on 30 patients.The cases in this study range from january 2014 to december 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 early infections, which required 1-stage surgical wound debridement and antibiotic therapy.

Manufacturer Narrative

This complaint has been generated based on findings identified during post market surveillance literature review published by the ¿department of trauma-, hand- and reconstructive surgery, university hospital jena, germany ¿.The article can be found at doi: 10.1097/bot.0000000000000829.  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 PRO 3D ANATOMICAL-PRESHAPED SUPRAPECTINEAL 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: 15569084
• MDR Text Key: 301486991
• Report Number: 0008031020-2022-00508
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 10/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/10/2022
• 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: 09/13/2022
• 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