MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH UNK - CONSTRUCTS: EX-FIX; APPLIANCE,FIXATION,NAIL

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

Patient Problems Tissue Damage (2104); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown ex-fix construct/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.(b)(4).

Event Description

This report is being filed after the review of the following journal article: atif m., mohib y., hasan o., rashid h., (2020)in the cost-conscious era: ilizarov circular frame or uniplanar external fixator for management of complex open tibia shaft fracture, retrospective cohort study from a level-1 trauma center, the journal of the pakistan medical association, volume 70, no.Supplement 1, pages s20-s23 (pakistan).This retrospective study aims to determine the outcome of open tibia shaft fracture treated with either ilizarov or ao external fixator in terms of fracture healing.Between 1st january 2008 and 31st december 2014, a total of 93 patients (10 males and 83 females)with a mean age of 36.7 ± 17.3 years with open tibia shaft fracture type iii (a, b, c) stabilized with external fixation were included in the study.These patients were divided into two groups according to the external fixator used.The fracture was treated with either ilizarov or ao external fixator.Circular fixator was used for 46 whereas 47 were treated with the uni-planar fixator.The fracture was treated with either ilizarov or ao external fixator.The following complications were reported as follows: unipalar fixator group: mean time of fracture healing for circular fixator was 9 months rust score for circular unipalar group is 7.3.3 cases of delayed union.-complications were found in 5 patients of the uni-planar group (pin site infection 2%, readjustment of fixator 4%, delayed union 6% and others (fat embolism 2%).In the uniplanar group, 25 patients had secondary procedures bone grafting,2 fixator readjustment, 2 conversionto plate,3 intramedullary nail , 10 conversion to circular fixator, and 8 cases of cast or splint.1 case of pin site infection.Readjustment of fixator this report is for an unknown synthes ao external fixator.It captures the reported event of readjustment of fixator.This is report 3 of 3 for complaint (b)(4).

• Brand Name: UNK - CONSTRUCTS: EX-FIX
• Type of Device: APPLIANCE,FIXATION,NAIL
• 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: 9983268
• MDR Text Key: 193971828
• Report Number: 8030965-2020-03008
• Device Sequence Number: 1
• Product Code: KTT
• Combination Product (y/n): N
• Reporter Country Code: PK
• 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: 04/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2020
• 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: 04/01/2020
• 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