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

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

Patient Problems Wound Dehiscence (1154); Failure of Implant (1924); Unspecified Infection (1930)

Event Type  Injury  

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 unk - constructs: veptr/unknown lot.Part and lot numbers are unknown; udi number is unknown.Device available for evaluation: complainant part is not expected to be returned for manufacturer review/investigation.Without a lot number, the device history records review could not be completed as no product was received.Based on the information available, it has been determined that no corrective and 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.

Event Description

This report is being filed after the review of the following journal article: elmallah r, et al.(2021), outcomes of vertical expandable prosthetic titanium ribs in children with early-onset scoliosis secondary to cerebral palsy, cureus 13(3): e13690.Doi 10.7759/cureus.13690 (usa).The purpose of the study was to investigate the use of veptr constructs to treat spinal deformity and thoracic insufficiency syndrome in patients with cerebral palsy.Between 2008 and 2017, 8 patients with neuromuscular scoliosis who received uknown synthes veptr constructs were included in the study.There were 6 females and 2 males.The mean age for initial placement of the veptr construct was 5.9 years (range: 3.1 to 8.7 years).The mean length of follow-up between the index surgery and latest available follow-up was 4 years (range: 2 to 6.5 years).After the veptr construct was removed, 4 patients required definitive posterior spinal fusions complications were reported as follows: patient 1 had infection, hardware exposure, and wound dehiscence.Patient 2 had infection.Patient 4 had rod migration.Patient 5 had infection and respiratory distress.Patient 6 had infection.Patient 7 had infection, hardware exposure, and wound dehiscence.This report is for the unknown synthes veptr instrumentation.This is report 6 of 6 for complaint (b)(4).

• Brand Name: UNK - CONSTRUCTS: VEPTR
• Type of Device: PROSTHESIS, RIB REPLACEMENT
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 15349818
• MDR Text Key: 299185397
• Report Number: 8030965-2022-06354
• Device Sequence Number: 1
• Product Code: MDI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/02/2022
• 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: 08/10/2022
• 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