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

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191)

Patient Problems Bone Fracture(s) (1870); Impaired Healing (2378)

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: dornacher d, et al.(2021), the degree of correction in open-wedge high tibial osteotomy compromises bone healing: a consecutive review of 101 cases, the knee, volume 29, pages 478-485.(germany).The aim of this examination was to analyse the risk factors leading to a disturbance in bone healing in our patient population treated with an open-wedge high tibial osteotomy due to early-stage unicompartmental varus osteoarthritis.Between 2011 and 2017, 96 patients (101 cases) who underwent an open-wedge high tibial osteotomy were included in the study.There were 27 females and 69 males with a mean age of 41.4 years (range, 17-64 years).After osteotomy, all tibiae were stabilized with an unknown synthes tomofix locking plate system.The mobilization of the patient started at the first postoperative day.Patients were allowed to have partial weight bearing for the first 6 weeks after the osteotomy.Independent of the additionally performed procedures, inpatient rehabilitation was offered to every patient, starting right after the follow up examination 6 weeks postoperatively.During this 3-week rehabilitation protocol, full weight bearing was achieved.The clinical and radiographic follow up was performed 3¿5 days after the intervention and continued at 6 weeks postoperatively.Complications were reported as follows: a total of 16 patients had disturbed bone healing.11 patients had 2 of the 3 corticalices were not healed at 18 months after the surgery.The removal of the locking plate was scheduled about 2 years after the osteotomy.No mechanical issues occurred in any of the patients after the removal of the fixation device.5 patients had none of the 3 corticalices healed at 18 months after the surgery.These patients underwent revision surgery, the gap was filled with autogenous cancellous bone and a mono- or tricortical bone graft from the iliac crest.A (b)(6) year-old patient had no progress in bone healing at 12 months postoperatively.The patient underwent revision surgery, the gap was filled with autogenous cancellous bone in advance of the removal of the locking plate.10 patients had disturbance of wound healing.31 patients had lateral hinge fractures.This report is for the unknown synthes tomofix locking plate system.This report is for (1) unk - constructs: tomofix plate/screws.This is report 2 of 2 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: 12548435
• MDR Text Key: 273892143
• Report Number: 8030965-2021-08132
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 08/31/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2021
• 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: 08/31/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention