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 Unspecified Infection (1930); Pain (1994); Tissue Damage (2104); Joint Disorder (2373); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown plate/screw constructs/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, k.-i., kim, g.B., kim, h.J., and song, s.J.(2018), does the pre-operative status of the anterior cruciate ligament affect the outcomes following medial open-wedge high tibial osteotomy?, the knee, vol.25 (6), pages 1197-1205 (korea, south).The aim of this study is to assess the morphological degeneration of the acl through magnetic resonance imaging (mri) and arthroscopy, and analyze whether pre-operative status of the acl would affect the radiologic and clinical outcomes following mowhto.Between february 2008 to october 2015, a total of 126 patients (13 males with 16 knees and 113 females with 134 knees) with a mean age of 56.1 years (range 45-67) underwent medial open-wedge high tibial osteotomy (mowhto) with a medial locked plate and concomitant first-look arthroscopic procedures.Surgery was performed using a medial locked plate (tomofix; synthes, solothurn, switzerland).In patients who had complete tear of the acl, isolated hto was performed without concomitant acl reconstruction.The mean follow-up period was 61.2months (range 24-120).The following complications were reported as follows: the acls were classified into intact (75 knees, 50.0%), mucoid degeneration (59, 39.3%), chronic partial tear (10, 6.7%), and complete tear (six, 4.0%) according to mri.The kellgren¿lawrence grade of these patients progressed in 32 knees and was stationary in 111 knees.They were also classified into four stages: normal (95 knees, 63.3%), abnormal (36, 24.0%), partial tear (13, 8.7%), and complete tear (six, 4.0%) according to arthroscopic appearance.The kellgren¿lawrence grade of these patients progressed in 32 knees and was stationary in 110 knees.1 patient complained of severe knee instability and related pain during the follow-up period and had a staged acl reconstruction at 10 months post-operation.1 patient with mucoid degeneration on mri and absent synovial coverage during arthroscopy was converted to total knee arthroplasty due to progressed oa.2 patients had postoperative infection at the site of the operation at four and 15 months postoperatively.They improved after incision and debridement of the surrounding soft tissue and insertion of antibiotic-impregnated beads.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: 10457330
• MDR Text Key: 204552856
• Report Number: 8030965-2020-06350
• 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

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