MAUDE Adverse Event Report: SYNTHES GMBH UNK - CONSTRUCTS: DYNAMIC COMPRESSION PLATE/SCREWS; PLATE, FIXATION, BONE

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

Patient Problems Ossification (1428); Necrosis (1971); Non-union Bone Fracture (2369); Post Operative Wound Infection (2446); Physical Asymmetry (4573)

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown 3.5 mm dcp plate/screw construct/unknown lot.Part and lot number are unknown.Without the specific part number; the udi number and 510-k number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

This report is being filed after the review of the following journal article: suarez r., barquet a., fresco r.,(2016) epidemiology and treatment of monteggia lesion in adults: series of 44 cases, acta ortopedica brasileira volume 24(1), pages 48-51(uruguay).This retrospective study aims to describe the characteristics, treatment and outcome of patients with monteggia lesion from two uruguayan institutions.Between 2006 and 2012, clinical records and radiographs of all adult patients (>18 years old) with monteggia lesion were reviewed.A total of 44 patients (27 males, 17 females) with a minimum follow-up after surgery of 18 months were identified.For the fixation of the ulnar fracture, osteosynthesis with a 3.5 mm dcp plate was performed as single implant in 30 cases, with one-third tubular plate in two cases, with 3.5 mm dcp plate and external fixators in four cases , with 3.5 mm reconstruction plate in one case and cerclage in eight cases.The following complications were reported as follows: complications 21 occurred in the first surgery: misalignment of the ulna, radio ulnar dislocation, nonunion of the ulna, necrosis of the radial head, postoperative infection, heterotopic ossification, delayed consolidation of the neck of the radius fracture, radio-ulnar synostosis, deficiency neuropathy, and posterolateral rotatory instability.15 that suffered complications needed reoperations.Four of 31 patients that had plates (dcp and reconstruction) required reoperation.While 11 out of 13 needed reoperation when a different osteosynthesis method was used.Regarding functional results these were unsatisfactory or bad in seven cases.Loosening of osteosynthesis of radial head and neck.Implant loosening.This report is for an unknown synthes 3.5 mm dcp plate/screw construct.It captures the reported adverse events of misalignment of the ulna, radio ulnar dislocation, nonunion of the ulna, necrosis of the radial head, postoperative infection, heterotopic ossification, delayed consolidation of the neck of the radius fracture, radio-ulnar synostosis, deficiency neuropathy, and posterolateral rotatory instability.This is report 1 of 3 for (b)(4).

• Brand Name: UNK - CONSTRUCTS: DYNAMIC COMPRESSION PLATE/SCREWS
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 11577630
• MDR Text Key: 255581316
• Report Number: 8030965-2021-02377
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: UY
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/01/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention