MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH UNK - PLATES; 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 dorsal plate (va-lcp forefoot/midfoot system)/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.(b)(4).

Event Description

This report is being filed after the review of the following journal article: malagelada, f., welck, m.And clark, c.(2017), the dowel technique for first metatarso-phalangeal joint arthrodesis in revision surgery with bone loss, foot and ankle surgery, vol.24, issue 3, pages 224-228 (united kingdom).The aim of this article is to present a novel technique of longitudinal (proximo-distal) bone dowel arthrodesis for first mtpj arthrodesis with bone loss and review the clinical and radiological outcomes of our technique.Between august 2007 and february 2015, a total of 8 patients (7 females and 1 male) with a mean age of 60.5 years (range 45-80) underwent fixation using a dorsal plate (va-lcp forefoot/midfoot system, synthes, welwyn garden city, uk).The mean length og post-operative follow-up was 37.4 months (range 12-102).The following complications were reported as follows: a (b)(6) year-old female patient had unremitting pain at the latest follow-up (38 months post-operation).Despite the absence of clinical signs.They suspected atypical complex regional pain syndrome (crps) and she was treated symptomatically.Her index surgery was for non-union.A (b)(6) year-old female patient required removal of metalwork due to discomfort.Her index surgery was for silastic.A (b)(6) year-old male patient had a prominent plate.His index surgery was for a non-union after malunion revision.An unknown patient had a partial loss of sensation in the big toe which resolved.Her index surgery was for non-union.This is report 7 of 8 for (b)(4).This is for a dorsal plate (va-lcp forefoot/midfoot system).

• Brand Name: UNK - PLATES
• 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: 8925142
• MDR Text Key: 155344161
• Report Number: 8030965-2019-67664
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 07/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/23/2019
• 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: 07/26/2019
• 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