MAUDE Adverse Event Report: SYNTHES GMBH UNK - VEPTR IMPLANTS; PROSTHESIS, RIB REPLACEMENT

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

Patient Problem Failure of Implant (1924)

Event Date 04/30/2021

Event Type  Injury  

Event Description

Device report from synthes reports an event in russia as follows: this report is being filed after the review of the following journal article: mikhaylovskiy mv, et al.(2021), final fusion in a complex of surgical treatment for early onset scoliosis, folia medica, volume 63(2), pages 264-271, doi:10.3897/folmed.63.E55955, (russia).The objective of the review is to evaluate the efficacy of final fusion following staged distraction with veptr instrumentation in patients with early onset scoliosis (eos).Between 2008 and 2017, 37 patients with eos of different etiology who underwent distraction-based program and final fusion surgery were included in the study.There were 22 girls and 15 boys.The patients had staged distraction-based procedures using the unknown synthes vertical expandable titanium rib prosthesis (veptr) instrumentation and final fusion using competitors hook-based systems, transpedicular constructs or hybrid instrumentation and autologous bone.The mean age at the first distraction with unknown synthes veptr device was 5.2 years (range, 1-9 years).The interval between staged distractions ranged between 9 to 12 months.The mean age at final fusion was 13.9 years (range, 11-17 years).The mean length of the final fusion was 13.4 (range, 9-16) vertebral segments with 1.5 segments exceeding the zone of instrumented spine during staged treatment.Complications were reported as follows: (during the distraction program only) 78 adverse events developed in 33 patients or there was a mean of 2.3 complications per patient.Most of the complications were implant-related.The adverse outcomes did not seriously affect the patients¿ condition and were arrested during the next phase of correction or the exchange of implants at final fusion.Unknown patients had rod fractures.Unknown patients had rod displacement.Unknown patients had failure of anchors.This report is for the unknown synthes veptr instrumentation.This is report 1 of 2 for complaint (b)(4).

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.This report is for an unknown veptr implants: distal e./unknown lot number.Without the specific part number, the udi number and 510k number is unknown.Device available for evaluation: complainant part is not expected to be returned for manufacturer review/investigation.Initial reporter name and address: (b)(6).Postal code (b)(4).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.

• Brand Name: UNK - VEPTR IMPLANTS
• Type of Device: PROSTHESIS, RIB REPLACEMENT
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kate karberg ; eimattstrasse 3; oberdorf ; SZ ; 6103142063
• MDR Report Key: 15348938
• MDR Text Key: 299173856
• Report Number: 8030965-2022-06333
• Device Sequence Number: 1
• Product Code: MDI
• Combination Product (y/n): N
• Reporter Country Code: RS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial

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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/10/2022
• Initial Date FDA Received: 09/02/2022
• 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