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

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Hematoma (1884); Unspecified Infection (1930); Unspecified Tissue Injury (4559); Insufficient Information (4580)

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.H10 additional narrative: d1, d2, d3, d4, g4 ¿ 510k: this report is for an unk - veptr implants: veptr ii/unknown lot.Part and lot numbers are unknown; udi number is unknown.D9: complainant part is not expected to be returned for manufacturer review/investigation.E3: reporter is a j&j employee.H3, h4, h6: 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.

Event Description

This report is being filed after the review of a clinical evaluation report (cer) from a related research activity database (ddra) for a total of 121 patients who were treated with depuy synthes veptr/veptr ii implants during mechanical stabilization and distraction of the thorax between january 1, 2004, and april 30, 2023.There were 65 males and 56 females with a mean age of 9 years.The following complications have been identified as per the premier healthcare database report: 7 patients had infection and underwent subsequent surgery.1 patient had hematoma and underwent subsequent surgery.3 patients had dural tear and underwent subsequent surgery.16 patients had device-related complication and underwent subsequent surgery.3 patients had wound related complication and underwent subsequent surgery.56 patients had encounter for device adjustment.7 patients had encounter for device removal.17 patients underwent spine fusion procedure.28 patients underwent device insertion.47 patients underwent device removal.240 patients underwent other procedures.This is for the unknown synthes spine veptr/veptr ii implants.This is report 1 of 1 for complaint (b)(4).A copy of the clinical evaluation form is being submitted with this regulatory report.

• Brand Name: UNK - VEPTR IMPLANTS: VEPTR II
• 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: 19053780
• MDR Text Key: 339554976
• Report Number: 8030965-2024-04604
• 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: Health Professional
• Reporter Occupation: Other Health Care Professional
• 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: 03/22/2024
• Initial Date FDA Received: 04/05/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention