MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH; PLATE, FIXATION, BONE

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

Patient Problems Arthritis (1723); Pain (1994); Injury (2348); Impaired Healing (2378)

Event Type  Injury  

Manufacturer Narrative

There are multiple patients.All known information is provided in the journal article.This report is for an unknown lcp/unknown lot.Part and lot number are unknown; udi number is unknown.There are multiple unknown dates of implantation between (b)(6) 2010 and (b)(6) 2013.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.(b)(4).

Event Description

This report is being filed after the review of the following journal article: lavini, f.Et al (2014), temporary bridging external fixation in distal tibial fracture, injury-international journal of the care of the injured, vol.45(s6), pages s58-s63 (italy).The aim of this study is to evaluate the clinical and radiological results of the treatment of distal tibial fractures using an early temporary external fixation followed by definitive reconstruction and stabilization.Also considered was a new stage possibility in treatment: the maintenance of the temporary bridging external fixation after orif to exploit ligamentotaxis during the first phases of bone healing.Between january 2010 and january 2013, a total of 40 consecutive patients (22 male and 18 female) with a mean age of 52 years (range, 17-82 years) were included in the study.These patients were divided into 2 groups: group a comprised of 10 patients treated with a temporary bridging external fixation that was maintained by orif to exploit ligamentotaxis during the first phases of bone healing while group b comprised of 30 patients, the external fixation was removed after the orif synthesis and a postoperative cast was applied.Open reduction and internal fixation (orif) was performed using plates and screws (locking compression plate (lcp) synthes).A clinical examination with american orthopaedic foot and ankle score (aofas) and x-ray control evaluation was made for all patients at 3, 6, and 12 months after the definitive treatment.The final follow-up was 12 months.The following complications were reported: 12 patients had fair aofas score at final follow-up.2 patients had poor aofas score at final follow-up.2 patients had early posttraumatic arthrosis in pilon fractures detected at 1-year follow-up.(both group a and b).2 patients (1 with malleolar fracture-dislocation and 1 with pilon fracture) had superficial infections.(both group a and b).3 patients with pilon fractures had delayed wound healing related to exposed fracture.(both group a and b).3 patients (2 with pilon fractures and 1 with malleolar fracture-dislocation) had reflex sympathetic dystrophy.(both group a and b).This report is for an unknown synthes locking compression plate.This is report 1 of 2 for (b)(4).

• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 8582352
• MDR Text Key: 144140882
• Report Number: 8030965-2019-63504
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: IT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/08/2019

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: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/08/2019
• Initial Date FDA Received: 05/06/2019
• 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