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

This report is for an unknown plate/screws construct/unknown lot.Part and lot number are unknown.Without the specific part number; the udi number and 510-k 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.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: kim, g.B., kim, k.-i., song, s.J., and lee, s.H.(2019), increased posterior tibial slope after medial open-wedge high tibial osteotomy may result in degenerative changes in anterior cruciate ligament, the journal of arthroplasty, vol.34 (9), pages 1922-1928 (korea, south).The aim of this retrospective study is to evaluate the changes in ptsa and the acl before and after mowhto through 2-staged arthroscopic findings and verify whether the acls would be affected by the changed ptsa.Between july 2010 to march 2016, a total of 128 patients (21 male and 107 female) with 164 knees, with a mean age of 57.2 ± 5.1 years (42-67) underwent mowhto and concomitant arthroscopy.Surgery was performed using a medial locked plate system (tomofix; depuy synthes, solothurn, switzerland).Plate removal and concomitant second-look arthroscopy were usually recommended for 2 years after index operation.The mean follow-up period was 70.2 months (23-104).The following complications were reported as follows: in 5 males and 29 females (45 knees), their acl had become worse (progressed group) after the second-look arthroscopy.In a (b)(6) year old female patient, ¿stage 2¿ acl with no synovial coverage was observed at first-look arthroscopy viewed from the anterolateral standard portal.At 26 months postoperatively, the second-look arthroscopy showed ¿stage 3¿ acl with partial tear of some fibers.This report is for an unknown synthes plate/screws constructs.It captures the reported female patients whose acl had become worse (progressed group).This is report 2 of 3 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: 10457200
• MDR Text Key: 204581680
• Report Number: 8030965-2020-06346
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: KS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2020
• 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: 08/03/2020
• 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