MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH; PLATE, FIXATION, BONE

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

Patient Problem Nerve Damage (1979)

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown synthes lateral locking plate/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.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: lee, j.E.Et al (2018).One-barrel microsurgical fibula flap for reconstruction of large defects of the femur.Microsurgery.Page 373-378.(south korea).The purpose of this study is to review the clinical outcomes of using a 1-barrel free vascularized fibular graft (fvfg) protected by a lateral locking plate for large femoral defects not involving the knee joint.Between august 2007 and august 2013, we treated 7 patients with large femoral bone defects after tumor resection.The mean age of the patients was 19 years (range, 12¿36 years), and 3 were women.All defects were free of infection before the procedure.Femoral bone defects were reconstructed using a 1-barrel fvfg protected by a lateral locking plate (depuy-synthes, west chester, pa) (fig.1).The mean bone defect size was 10.5 cm (range, 6¿16 cm).All patients survived beyond the last follow-up; the mean follow-up period was 54 months (range, 26¿100 months).Healing and graft hypertrophy was evaluated by examining repeated plain x-rays.Isotope scanning was used to evaluate graft perfusion, local recurrence, and bone metastases in all cases.Clinical outcome was assessed by the musculoskeletal tumor society (msts) score, which evaluates pain, functional activity, emotional acceptance, need for external support, walking ability, and gait.The complications were reported as follows: case 5 - (b)(6) year-old female patient had locking screw breakage which occurred 3 months after the fvfg procedure.The lateral locking plate was replaced with a longer one for successful bone reconstruction 28 months postoperatively (fig.4).The patient sustained peroneal nerve palsy due to limb lengthening, but was managed conservatively, and was walking without walking aids at the last follow-up (fig.5).Leg length discrepancy (lld) was reported in 4 cases and was managed conservatively, except in 1 case.This report is for a (b)(6) year old patient who sustained peroneal nerve palsy due to limb lengthening.This report is for an unknown synthes lateral locking plate.This is report 1 of 4 for (b)(4).

• 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: 8360001
• MDR Text Key: 136810247
• Report Number: 8030965-2019-61265
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2019
• 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: 01/29/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 13 YR