MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH UNK - PLATES: TOMOFIX OSTEOTOMY; PLATE, FIXATION, BONE

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

Patient Problems Hematoma (1884); Blood Loss (2597); No Code Available (3191)

Event Date 01/13/2020

Event Type  Injury  

Manufacturer Narrative

Additional narrative: -510k: 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.

Event Description

This report is being filed after the review of the following journal article: kim k., kim b., lee m., song s., (2020)do we need chemoprophylaxis to prevent venous thromboembolism following medial open-wedge high tibial osteotomy?, the journal of knee surgery xxxxx, pages 1-7 (korea, south) this study aims to investigate the incidence of vte following mowhto in asian patients.From (b)(6) 2012 to (b)(6) 2016, a consecutive series of 146 patients who underwent mowhto with a medial locked plate system for the treatment of medial compartment osteoarthritis with the minimum follow-up of 2 years after surgery were considered for inclusion in this study.A total of 133 patients were enrolled in this study.Patients were assigned into two groups: chemoprophylaxis group with 66 patients (8 males, 58 females) age55.9 - 4.9 and control group,patients in this group did not receive any chemoprophylaxis for vte, with 67 patients (6 males, 61 females) age 56.1 - 5.1.A medial locked plate (tomofix; synthes, solothurn, switzerland) was used with locking screws.All patients were then followed-up subsequently at 6 weeks and 3, 6, and 12 months postoperatively and then every year until last follow-up.The following complications were reported as follows: -overall postoperative dvt was diagnosed in 10 patients in the control group and 7 patients in the chemoprophylaxis group, although all cases were clinically asymptomatic.-proximal dvt was diagnosed in only one patient (1/67, 1.5%) in the control group.-minor bleeding occurred in four patients (4/66, 6.1%) from the chemoprophylaxis group.-3 cases of ecchymosis in chemoprophylaxis group.-1 case of hematoma in chemoprophylaxis group.This report is for an unknown synthes medial locked plate tomofix.A copy of the literature article is being submitted with this medwatch.This is report 1 of 2 for (b)(4).

• Brand Name: UNK - PLATES: TOMOFIX OSTEOTOMY
• 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: 10474797
• MDR Text Key: 213478557
• Report Number: 8030965-2020-06503
• 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: 08/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2020
• 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: 08/06/2020
• 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