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

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

Patient Problems Impaired Healing (2378); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Brand name, common device name, procode, mfr, lot #, part #, udi #, 510k: this report is for an unknown vertical expandable prosthetic titanium rib (veptr) /unknown lot.Part and lot number are unknown.Without the specific part number; the udi number and 510-k number is unknown.Device available for evaluation: complainant part is not expected to be returned for manufacturer review/investigation.(b)(4).Device evaluated by mfr, manufacture date: 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: mak, h.Et al (2017), the use of magnetically-controlled growth rods (mcgr) and traditional growth rods (tgr) in a paediatric population, the spine journal, vol.17 (no.11), pages s331 (ireland).The aim of this single-center prospective study is to evaluate clinical outcomes in both magnetically controlled growth rods (mcgr) group and traditional growth rods (tgr) group.Between 2012 to 2016, a total of 47 patients (28 males and 19 females) were included in the study.Of these, 24 patients were treated using traditional growth rods (veptr or competitor¿s device).7 out of 24 patients were converted from traditional growth rods to magnetically controlled growth rods.The following complications were reported as follows: 7 patients in traditional growth rods were converted to magnetic-controlled growth rods (mcgr).5 patients had wound-related complications.2 had respiratory complications.9 patients underwent revision.2 patients experienced postoperative rod fracture and breakage.This report captures the adverse events of surgical intervention, medical device removal, wound healing delayed and conversion/ revision to another device.This report is for an unknown synthes vertical expandable prosthetic titanium rib (veptr).This is report 1 of 2 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 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 8708371
• MDR Text Key: 148314927
• Report Number: 8030965-2019-65420
• Device Sequence Number: 1
• Product Code: MDI
• Combination Product (y/n): N
• Reporter Country Code: EI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/18/2019
• 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: 05/22/2019
• 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