MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH UNK - CONSTRUCTS: VEPTR; PROSTHESIS, RIB REPLACEMENT

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

Patient Problems Nerve Damage (1979); 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: gomesa, c.Et al (2015), monopolar-probe monitoring during spinal surgery with expandable prosthetic ribs, orthopaedics & traumatology: surgery & research volume 101(4),june 2015,pages s193-s197 (france).The primary objective of this study was to assess the reliability of our technique for brachial plexus monitoring by comparing the stability of neurogenic mixed evoked potentials (nmeps) at the upper and lower limbs with patients during vertical expandable prosthetic titanium rib (veptr) procedures.Where injuries to the spinal cord and brachial plexus have been reported after veptr implantation in 2 and 5% of patients, respectively.Between january 1, 2012 and september 1, 2014, twelve vertical expandable prosthetic titanium rib (veptr) procedures performed in 6 patients (3 male 3 female) with a mean age of 7.2 years (range, 6.1¿7.9 years) at first veptr implantation were monitored using a monopolar stimulating probe and were included in the study.The keypoint®4.2 system(medtronic,minneapolis, mn, usa), a commercially available intraoperative monitoring (iom) device was used.The following complications were reported as follows: adverse event in the right upper limb during the distraction procedure in 1 patient, with a good outcome.Neurogenic mixed evoked potential (nmep) amplitude dropped sharply then recovered totally after an alert by the neurophysiologist and promoted the surgeon to lift the distraction applied by the vertical expandable prosthetic titanium rib.This report is for an unknown vertical expandable prosthetic titanium rib (veptr).This is report 1 of 1 for 1 for (b)(4).

• Brand Name: UNK - CONSTRUCTS: VEPTR
• 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: 8732652
• MDR Text Key: 149129625
• Report Number: 8030965-2019-65722
• Device Sequence Number: 1
• Product Code: MDI
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 05/31/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/25/2019
• 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: 05/31/2019
• 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