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

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

Patient Problems Non-union Bone Fracture (2369); Joint Disorder (2373)

Event Type  Injury  

Manufacturer Narrative

This report is for unknown constructs: plate / screws unknown lot.Part and lot numbers are unknown; udi 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.(b)(4).

Event Description

This report is being filed after the review of the following journal article: bisicchia, s.And tudisco, c.(2016), radial head and neck allograft for comminute irreparable fracture-dislocations of the elbow, orthopedics, vol.39 (6), pages e1205-e1208 (italy).This study presents a case report of a (b)(6) year-old male patient who sustained an elbow dislocation with a comminuted fracture of the radial head and neck with severe bone loss.Surgery was performed using a 3.5-mm limited contact dynamic compression plate (synthes, west chester, pennsylvania) and sutured with a competitor¿s devices.The patient was followed clinically and radiographically at 3 months, 6 months, 1 year, and then annually.At final follow-up, 4 years postoperatively, the patient showed good range of motion of his left elbow.He lacked approximately 20° of supination, but this did not affect his work and/or everyday activities.Radiographs at final follow-up showed stable concentric reduction of the elbow with mild degenerative changes.There was some osteolysis around the screws that were coming loose, and the radial head had partially collapsed into valgus (figure 6).Mild screw loosening was noticed for the first time 3 years postoperatively, but subsequent evaluation at 4 years did not show progression.This report is for an unknown synthes plate and screws construct and unknown synthes screws.This report is for one (1) unk - constructs: plate / screws.This is report 1 of 2 for (b)(4).

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: b6.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.

• Brand Name: UNK - CONSTRUCTS: PLATE/SCREWS
• Type of Device: PLATE, FIXATION ,BONE
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 9306362
• MDR Text Key: 165974416
• Report Number: 8030965-2019-70190
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Type of Report: Initial,Followup
• Report Date: 10/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/11/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/11/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 45 YR