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

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Failure of Implant (1924)

Event Type  Injury  

Manufacturer Narrative

This report is for one (1) unknown vertical expandable prosthetic titanium rib (veptr) lamina hooks.Part and lot numbers are unknown.Without the specific part and lot number, the udi is not available.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.The investigation could not be completed; no conclusion could be drawn, as no product was received.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 subsequent review of the following literature article: konieczny (2017) vertical expandable prosthetic titanium ribs (veptr) in early-onset scoliosis: impact on thoracic compliance and sagittal balance.Journal of children's orthopaedics.Volume 11, pages 42-48.Germany.The aim of our study was to investigate the impact of scoliosis on thoracic compliance and also to analyze the quality of deformity correction in the coronial plane and the impact of veptr on sagittal balance (sagittal plane).This article is a retrospective review of a study conducted between 2004 to 2011 in which 21 consecutive children treated with vertical expandable prosthetic titanium ribs (veptr) were analyzed.The mean age at initial surgery was 5.26 years.After initial surgery, these patients had elongation procedures every six months.Follow-up was 60.67 months.The following complications were recorded: five patients sustained mechanical complications: three rib¿anchor dislocations, one lamina hook dislocation and two rod breakages.Three patients sustained soft-tissue complications from implant-related ulcers.Two patients could be managed by local revision and one patient received defect repair by a local musculocutaneous flap.A copy of the literature article is being submitted with this medwatch.This report is for one (1) unknown vertical expandable prosthetic titanium rib (veptr) lamina hooks.This is report 2 of 4 for complaint (b)(4).

• Type of Device: PROSTHESIS, RIB REPLACEMENT
• Manufacturer (Section D): OBERDORF : SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: michael cote ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 7260377
• MDR Text Key: 99605966
• Report Number: 8030965-2018-51001
• Device Sequence Number: 1
• Product Code: MDI
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 01/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2018
• 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: 01/17/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention