MAUDE Adverse Event Report: SYNTHES GMBH UNK - CONSTRUCTS: TOMOFIX PLATE/SCREWS; PLATE, FIXATION, BONE

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

Patient Problem Bone Fracture(s) (1870)

Event Type  Injury  

Manufacturer Narrative

This report is for an unk - constructs: tomofix plate/screws/unknown lot.Part and lot numbers are unknown; udi number is unknown.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.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: lee s-m, et al (2021), joint space width increases medially and decreases laterally at different time points after medial open-wedge high tibial osteotomy, arthroscopy: the journal of arthroscopic and related surgery, pages 1-8, (south korea) this study aims to evaluate the serial changes in the joint space width (jsw) of the medial and lateral compartments after medial open-wedge high tibial osteotomy (mowhto) and its associated factors.Between 2011 and 2016, 71 patients with symptomatic medial-compartment oa with varus alignment of the affected lower limb who underwent mowhto with locking-plate fixation and were followed up for at least 2 years postoperatively were included in this study.There were 16 males and 55 females with a mean age of 57.58+/-6.01 years and mean bmi of 26.27+/2.45 kg/m2.All patients were implanted with the unknown synthes tomofix device for proximal tibia fixation.On the day after surgery, the patients began performing continuous passive motion exercises.Weight bearing was gradually introduced, from toe touch during the first 2 weeks to full weight bearing at 6 to 8 weeks postoperatively.Postoperative rehabilitation was continued for 3 months, focusing on attaining full range of motion and strengthening the quadriceps.The mean follow-up was 3.96+/-1.46 years.Complications were reported as follows: 17 patients had lateral hinge fracture confirmed on follow-up radiographs and were excluded from the study.2 patients had revision surgery and were excluded from the study.This report is for the unknown synthes tomofix locking plate.A copy of the literature article is being submitted with this medwatch.This report is for one (1) unk - constructs: tomofix plate/screws.This is report 1 of 1 for complaint (b)(4).

• Brand Name: UNK - CONSTRUCTS: TOMOFIX PLATE/SCREWS
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 12562276
• MDR Text Key: 274283446
• Report Number: 8030965-2021-08245
• 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: foreign,health professional,l
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/01/2021

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: 09/01/2021
• Initial Date FDA Received: 10/01/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention