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

Device Problem No Apparent Adverse Event (3189)

Patient Problem No Code Available (3191)

Event Date 11/04/2010

Event Type  Injury  

Manufacturer Narrative

Brand name, common device name, procode, mfr, lot #, part #, udi #, 510k: this report is for an unknown constructs: veptr/unknown lot.Part and lot numbers are unknown; udi number is unknown.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.(b)(4).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: martin lacher et, al (2011), veptr (vertical expandable prosthetic titanium rib) treatment for jeune syndrome, european journal of pediatric surgery vol.21(2), pages 138-140 (germany).The aim of this study is to preserve thoracic function, volume, and diaphragm function.Although different medical and surgical options have been described in selected cases, most provide a static solution incapable of responding to the growth demands of thriving patients.This study presents a case of a (b)(6) female was diagnose with jeune syndrome.This patient with thoracic insufficiency syndrome (tis) was treated with vertical expandable prosthetic titanium rib (veptr).The mean duration of follow-up was unknown.The following complications were reported as follows: readmission for veptr placement on the left side was scheduled at the age of (b)(6).Several pneumonias with respiratory insufficiency.After a second, bilateral expansion at the age of (b)(6) following long-term mechanical ventilation and due to increased scoliosis, additional right-sided expansions were performed at the age of (b)(6).Despite several expansions, respiratory insufficiency has not markedly improved.The right lung remains hypoventilated, the left lung shows compensatory emphysema.This report is for one (1) unknown synthes veptr.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.H3, h6: investigation summary product was not returned.Based on the information available, it has been determined that no corrective and preventive 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.H11: d10: complainant part is not expected to be returned for manufacturer review/investigation.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.

• Brand Name: UNK - CONSTRUCTS: VEPTR
• Type of Device: PROSTHESIS, RIB REPLACEMENT
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 8798608
• MDR Text Key: 151309138
• Report Number: 8030965-2019-66296
• Device Sequence Number: 1
• Product Code: MDI
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 06/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/20/2019
• Initial Date FDA Received: 07/17/2019
• Supplement Dates Manufacturer Received: 07/18/2019
• Supplement Dates FDA Received: 08/13/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Weight: 4