MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH UNK - PLATES: 2.4 MM VARIABLE ANGLE LCP VOLAR RIM DISTAL RADIUS PLATE; PLATE,FIXATION,BONE

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

Patient Problems Unspecified Infection (1930); Nerve Damage (1979); Non-union Bone Fracture (2369); No Code Available (3191)

Event Date 03/19/2020

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown plates: 2.4 mm variable angle lcp volar rim distal radius plate/unknown lot.Part and lot numbers are unknown; udi number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.(b)(4).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.Investigation summary: product was not returned.Based on the information available, it has been determined that no corrective and 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: chang f., et al (2020) evaluating the necessity of bone augmentation for distal radius fracture fixed with a volar locking plate: a retrospective study, bmc musculoskeletal disorders volume 21, pages 1-10 (taiwan).This retrospective cohort study aims to hypothesized that surgical fixation of distal radius fractures using a volar locking plate with intraoperative bone augmentation could effectively prevent metaphyseal collapse and observe its effect for internal fixation with and without bone augmentation on postoperative radiographic outcomes by comparing x-ray images immediately and at 6 months after surgery.Between january 1, 2014, and december 31, 2016 391 xray images of patients undergoing surgery for distal radius fracture were examined.105 fractures , patients , (60 females, 45 males) with average age of 50.8 years (range: 19¿83 years) met the inclusion criteria.In all patients, internal fixation was performed using the depuy variable angle lcp two-column volar distal radius plate 2.4 mm® (depuy synthes, oberdorf, switzerland).In 88 cases, only the volar locking plate was used; these patients were designated as group 1 (gp1).In the other 17 cases, a plate was used with bone augmentation; these patients were designated as group 2 (gp2).Of the 105 patients, 54 were diagnosed with comminuted fracture types (ao-type 23-a3, c2, c3).These patients were also divided into a non-bone augmentation group (gp1) and a bone augmentation group (gp2) with 38 and 16 patients, respectively.The patients were followed up postoperatively for at least 6 months.The following complications were reported as follows: two patients (one in each group) had not met the criteria for the union, but both their russ scores were 5 points.Complications were noted in nine patients of gp1: six patients presented symptoms of carpal tunnel syndrome (three of them required implant removal after bone union) another two patients had acute surgical site infection (both resolved after oral antibiotics treatment), and the other patient suffered from de quervain syndrome, which resolved after local injection treatment.Complications were noted in two patients of gp2: an extraosseous bone substitute was present in ten patients, and two of them presented symptoms of carpal tunnel syndrome, and both of them required implant removal after the bone union.The extraosseous material had disappeared in six of the ten patients by 6 months.Of the 54 patients, diagnosed with comminuted fracture types (ao-type 23-a3, c2, c3), only one failed to meet the criteria for union and had a c2 fracture and required bone augmentation.Significant dorsal collapse and radial height shortening was noted at the 6-month follow-up in both the non-augmentation and augmentation groups.This report is for an unknown synthes variable angle lcp two-column volar distal radius plate 2.4 mm®.This report is for one (1) unk - plates: 2.4 mm variable angle lcp volar rim distal radius plate.This is report 1 of 2 for (b)(4).

• Brand Name: UNK - PLATES: 2.4 MM VARIABLE ANGLE LCP VOLAR RIM 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 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 10410422
• MDR Text Key: 209775986
• Report Number: 8030965-2020-06030
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: TW
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/14/2020
• 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: 07/22/2020
• 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