MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH; PROSTHESIS, RIB REPLACEMENT

Device Problem Migration (4003)

Patient Problem Failure of Implant (1924)

Event Type  Injury  

Manufacturer Narrative

Group ii consisted of 6 patients (1 male 5 female) with an average age at the beginning of the treatment was 4 (range: 1.6-6.6) years, were treated with veptr technique.This report is for an unknown veptr lamina hook/unknown lot.Part and lot number 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: atici, y., akman y., balioglu m., erdogan s.(2015), a comparison of the effects of two different techniques on shoulder balance in the treatment of congenital, journal of craniovertebral junction & spine (2015) volume 6(4),pages 190-194 (turkey).This study aims to evaluate how the two different growth guidance techniques radiologically effect on shoulder balance in the treatment of congenital scoliosis.Between 2004 to 2011, a total of 13 patients (2 male 7 female) with congenital scoliosis who underwent operation were included in the study.These patients were divided into 2 groups.Group i consisted of seven patients (1 male 6 female) with an average age at the beginning of the treatment was 7.5 (range: 4.6-10) years, were treated with a dual growing rod.Group ii consisted of 6 patients (1 male 5 female) with an average age at the beginning of the treatment was 4 (range: 1.6-6.6) years, were treated with veptr technique.The average follow-up periods for group 1 and group 2 were 4.2 (range: 2-7) years and 4.7 (range: 2-6) years, respectively.The following complications were reported as follows: group 2: 5 of the 6 patients had these complications consisted of: 3 cases of proximal cradle migrations.3 cases of distal cradle migrations.2 cases of hook displacement.2 cases of deep wound infection.1 case of rod fracture.This report is for an unknown veptr lamina hook.This is report 4 of 6 for (b)(4).

• Type of Device: PROSTHESIS, RIB REPLACEMENT
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 8688148
• MDR Text Key: 147636517
• Report Number: 8030965-2019-65189
• Device Sequence Number: 1
• Product Code: MDI
• Combination Product (y/n): N
• Reporter Country Code: TU
• 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: 05/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/11/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/15/2019
• 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