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 Arthritis (1723); Unspecified Infection (1930); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown medial locked plate (tomofix)/ 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.Et al.(2018), extra-articular lateral hinge fracture does not affect the outcomes in medial open-wedge high tibial osteotomy using a locked plate system, arthroscopy: the journal of arthroscopic and related surgery, vol 34, no 12 pages, 3246-3255, (south korea).The purpose of this study was to compare the radiologic and clinical outcomes in patients with and without lateral hinge fractures (lhfs) during medial open-wedge hight tibial osteotomy (mowhto) using a locked plate system, as well as to assess whether lhfs could affect the midterm outcomes.From may 2008 to november 2015, a total of 164 knees in 137 patients (125 women and 12 men) were included in this study.The average age at operation was 56.0 years (range, 42-67 years), these patients underwent mowhto with a medial locked plate (tomofix; synthes, solothurn, switzerland).The average follow-up period was 62.2 months (range, 24-120 months).The following complications were reported as follows: 37 knees had lateral hinge fractures.The osteotomy opening distance in the lhf groups was significantly larger than that in the nonfracture group.1 patient had revision high tibial osteotomy was performed 6 weeks postoperatively because of an inadequate plate position.1 patient had a conversion to total knee arthroplasty 7 years postoperatively owing to arthritic progression.2 patients had late infections: 1 with a type ii lhf at 15 months postoperatively and the other without an lhf at 4 months postoperatively.Both improved after incision and debridement of surrounding tissue and insertion of antibiotic-impregnated beads.Neither showed correction loss or union problems.This report is for an unknown synthes medial locked plate (tomofix; synthes, solothurn, switzerland).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: 10480078
• MDR Text Key: 205254692
• Report Number: 8030965-2020-06534
• 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: 08/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2020
• 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: 08/07/2020
• 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