MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH UNK - PLATES: LCP DIA-META VOLAR DISTAL RADIUS PLATE; PLATE, FIXATION ,BONE

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

Patient Problems Arthritis (1723); Synovitis (2094); Reaction (2414); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

There are multiple patients all information is provided in the article.This report is for an unknown lcp dia-meta volar distal radius plate/unknown lot.Part and lot number are unknown; udi number is unknown.Implant date is between 2000 to 2005.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.(b)(4).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: arora r, et al.(2009), a comparative study of clinical and radiologic outcomes of unstable colles type distal radius fractures in patients older than 70 years: nonoperative treatment versus volar locking plating, j orthop trauma, volume 23, page 237-242, (austria) the specific aim of this retrospective study was to compare the functional outcomes of surgical treatment (volar plating) and nonsurgical treatment (plaster immobilization) for the management of unstable distal radius fractures in independent patients older than 70 years.From 2000 to 2005, 114 patients who were 70 years and older and were treated for fractures of the distal radius were included in the study.There were 36 men and 78 women with a mean age of 79 years (range, 70¿97 years).61 patients declined surgical treatment and were treated with plaster cast immobilization (cast).Meanwhile, 53 of these patients (17 men, 36 women) with a mean age of 76 years (range, 70¿89 years) decided to have surgery and were treated with open reduction and internal fixation (orif) using volar interlocking plate systems.39 were treated using an unknown synthes 2.4mm locking compression plate distal radius plate and 14 patients were treated using a competitor¿s device.After surgery, the wrist was immobilized in a below-elbow splint for approximately 2 weeks.Active digital range of motion (rom) was started immediately.The mean follow-up time for group a (orif) was 51.5 months (range, 12¿64 months) and for group b (cast) was 62.2 months (range, 12¿81 months) the authors did not specify which patients were implanted with the synthe device.Thus, complications will be reported as follows: 2 patients with intraarticular fractures had stage 1 arthritis.7 patients with intraarticular fractures had stage 2 arthritis.12 patients with extra-articular fractures had stage 1 arthritis.1 patient with extra-articular fractures had stage 2 arthritis.2 patients had flexor tenosynovitis aggravated by the position of the plate on the palmar rim of the distal radius surface, distal to the watershed line.These patients were treated by removal of the implant after a mean of 5 months.2 patients had extensor tenosynovitis because of screw penetration into the dorsal radius cortex.1 patient had the extensor pollicis longus tendon was ruptured due to a locking screw penetrating the third extensor compartment.The plate was removed after 6 months and the extensor pollicis longus was reconstructed by transferring the indicis proprius tendon.A 75-year-old woman had delayed fracture union.Union was achieved after 16 weeks.A 70-year-old woman had a carpal tunnel syndrome observed after a mean of 9 months.The carpal tunnel was released and the plate removed.This report is for an unknown synthes 2.4mm locking compression plate distal radius plate and unknown synthes screws.This report is for one (1) unknown lcp dia-meta volar distal radius plate.This is report 1 of 5 for (b)(4).

• Brand Name: UNK - PLATES: LCP DIA-META VOLAR DISTAL RADIUS PLATE
• 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 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 10442313
• MDR Text Key: 212863027
• Report Number: 8030965-2020-06237
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: AU
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2020
• 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: 08/10/2020
• 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