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 Injury (2348); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

There are multiple patients.All known information is provided in the literature article.This report is for an unknown plate and screw construct/unknown lot.Part and lot number are unknown; udi number is unknown.Date of implantation is an unknown date between october 2014 and august 2016.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.

Event Description

This report is being filed after the review of the following journal article: ogawa, h., matsumoto, k., and akiyama, h.(2019), effect of increased posterior tibial slope on the anterior cruciate ligament status in medial open wedge high tibial osteotomy in an uninjured acl population, orthopaedics & traumatology: surgery & research, vol.105 (6), pages 1085-1091 (japan).The aim of this retrospective study is to perform an arthroscopic acl evaluation, to measure anterior tibial translation and to radiographically assess ptsa before and after owhto to clarify the relationship between ptsa and acl condition and function.Between october 2014 to august 2016, a total of 67 patients (18 male and 49 female) with 75 knees, with a mean age of 63.5±7.8 years (range 37-80) were treated with open wedge high tibial osteotomy (owhto).Surgery was performed using either a tomofix plate (depuy synthes, switzerland) or a competitor's device.The mean follow-up period was unknown.The following complications were reported: 10 cases (high-grade group) had partial or complete acl tear (3 or 4 points) at the second-look arthroscopy as compared with 2 cases (low-grade group) at the index arthroscopy.65 knees were low-grade at the second-look arthroscopy.This report is for an unknown synthes plate/screws constructs.This is report 1 of 1 for (b)(4).

• 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
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 10507765
• MDR Text Key: 206341563
• Report Number: 8030965-2020-06681
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 08/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2020
• 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: 08/12/2020
• 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