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

Catalog Number UNK_SEL

Device Problems Break (1069); Fracture (1260)

Patient Problem Failure of Implant (1924)

Event Date 11/06/2021

Event Type  malfunction  

Event Description

The manufacturer became aware of a literature published by the ¿department of orthopaedic, clínica dávila, surgery, chile¿.The title of this report is ¿fixation failure in patients with traumatic diastasis of pubic symphysis: impact of loss of reduction on early functional outcomes¿, published on (b)(6) 2021, and can be found at https://doi.Org/10.1186/s13018-021-02802-x.The report is associated with the stryker ¿matta pelvic system ¿ and includes an analysis of the clinical data that was collected on 37 patients.The cases in the study range from january 2016 and december 2018.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 13 patients experienced fixation failure.The report states, ¿fixation failure (ff) was defined as presence of plate or screw breakage and screw loosening.¿.

Manufacturer Narrative

This record is a consolidation of events summarized as part of literature review when device and patient information is not available.This complaint has been generated based on findings discovered during post market surveillance literature review.The alleged event of fixation failure 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 medical history, the event circumstances, radiographs and the involved device(s) must be available in order to determine the root cause.If any additional information becomes available, the investigation will be reopened and re-evaluated accordingly.Device disposition unknown.

Manufacturer Narrative

Please note correction to b1.

Event Description

The manufacturer became aware of a literature published by the ¿department of orthopaedic, clínica dávila, surgery, chile¿.The title of this report is ¿fixation failure in patients with traumatic diastasis of pubic symphysis: impact of loss of reduction on early functional outcomes¿, published on november 06, 2021, and can be found at https://doi.Org/10.1186/s13018-021-02802-x.The report is associated with the stryker ¿matta pelvic system ¿ and includes an analysis of the clinical data that was collected on 37 patients.The cases in the study range from january 2016 and december 2018.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 13 patients experienced fixation failure.The report states, ¿fixation failure (ff) was defined as presence of plate or screw breakage and screw loosening.¿.

• Brand Name: UNKNOWN MATTA 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: 15142923
• MDR Text Key: 297029989
• Report Number: 0008031020-2022-00367
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: CI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Literature
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/01/2022
• 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: 08/03/2022
• 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): Other