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

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

Patient Problem Seroma (2069)

Event Type  Injury  

Event Description

Device report from synthes reports an event in greece as follows: this report is being filed after the review of the following journal article: kostopanagiotou k., steimer d.A., wojtys m.E., and wee j.O.(2021), chest wall reconstruction for sarcoma with vertical expandable prosthetic titanium ribs.First reported use in an adult patient, kardiochirurgia i torakochirurgia polska, vol.18 (4), pages 262-264 (greece).This study presents a case report of a 24-year-old male patient who presented with recurrence of a previously resected sarcoma of the right hemithorax.He underwent reoperation with reconstruction in the left lateral decubitus position and double lumen ventilation.An extended posterolateral thoracotomy was performed and the subcutaneous tissues were dissected off meticulously to keep the tumor¿s capsule intact.The 3rd to 7th ribs were resected and the mass was removed en-bloc with the inferior part of the scapula and part of the right hemi-diaphragm, which were also infiltrated.The complete specimen measured 30 × 25 cm and was resected at macroscopic clear margins.No lung parenchyma was infiltrated.The resulting defect required reconstruction with rigid prosthesis and patch.Two veptr-ii rods were cut manually and bent in the custom length and shape.Each bar is composed of two parts fitting one inside the other at mid-length and then anchored around the rib with a ring-type locking mechanism.No securing screws are drilled on the ribs.The 2nd to 8th ribs were bridged vertically with two rods of the veptr system.For completion two synthetic non-absorbable patches were secured superficially to the rods with non-absorbable sutures.A previously prepared omental flap filled the space between the synthetic patch and the subcutaneous tissues.The large defect was restored in shape and volume.Finally, two 28fr chest drains and a single subcutaneous vacuum drain were inserted.Extubation and postoperative breathing effort were normal.At the second postoperative week a subcutaneous seroma formed, which was aspirated regularly for 3 weeks.This report is for an unknown synthes veptr ii.This is report 1 of 1 for (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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.This report is for an unknown constructs: veptr ii/unknown lot.Part and lot number are unknown.Without the specific part number; the udi number and 510-k number is unknown.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.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 - CONSTRUCTS: 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: 15282680
• MDR Text Key: 298484161
• Report Number: 8030965-2022-05966
• 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: Foreign,Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup

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: 08/24/2022
• Supplement Dates Manufacturer Received: 08/31/2022
• Supplement Dates FDA Received: 09/22/2022
• 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
• Patient Age: 24 YR
• Patient Sex: Male