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

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

Patient Problems Pocket Erosion (2013); Skin Irritation (2076); No Code Available (3191)

Event Date 09/10/2015

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown constructs: veptr/unknown lot number.Without the specific part number, the udi number and 510k number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.(b)(4).The reported event required medical/surgical intervention to preclude permanent damage to a body structure and for surgical intervention, medical device removal skin breakdown related prominent implant.Without a lot number, the device history records review could not be completed as no product was received.The investigation could not be completed; no conclusion could be drawn at the time of filing this report.Investigation summary 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, 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

Device report from synthes reports an event in (b)(6) as follows: this report is being filed after the review of the following journal article: rolton, d., thakar, c., wilson-macdonald, j.And nnadi, c.(2016), radiological and clinical assessment of the distraction achieved with remotely expandable growing rods in early onset scoliosis, european spine journal, vol.25 (10), pages 3371-3376 (united kingdom).The aim of this prospective study is to radiographically evaluate the true amount of remote distraction achieved with repeated distractions up to 3 years post-implantation and correlate this with clinical growth parameters.Between december 2011 to may 2014, a total of 21 patients (11 males and 10 females) with an average age of 7.8 years (3¿12 years) were included in the study.Only 2 out of 21 patients were implanted with vertical expandable prosthetic titanium rib (veptr).The average follow-up was 24 months (7¿37 months).The following complications were reported as follows: a (b)(6) year-old female patient was converted from veptr to competitor's device.A (b)(6) year-old male patient was converted from veptr to competitor's device.3 patients had failure of fixation at an anchor point that required unplanned surgery (the article did not indicate if patients who had complications were implanted with veptr).1 patient had skin break down over a prominent metalwork that required unplanned surgery (the article did not indicate if patients who had complications were implanted with veptr).2 patients had rod breakage that required unplanned surgery (the article did not indicate if patients who had complications were implanted with veptr).This report is for an unknown synthes veptr construct and unknown veptr implants.This report is 4 of 5 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 ; eimattstrasse 3; oberdorf 4436 ; SZ 4436 ; 6103142063
• MDR Report Key: 8852785
• MDR Text Key: 153090518
• Report Number: 8030965-2019-66768
• Device Sequence Number: 1
• Product Code: MDI
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 07/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/01/2019
• 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: 07/05/2019
• 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