MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC UNK - CONSTRUCTS: VEPTR II; PROSTHESIS, RIB REPLACEMENT

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

Patient Problems Non-union Bone Fracture (2369); Impaired Healing (2378)

Event Type  Injury  

Manufacturer Narrative

This report is for an unk - constructs: veptr/unknown lot.Part and lot numbers are unknown; udi number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.Reporter is a j&j employee.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 396 patients (209 female, 187 males) with early onset scoliosis primarily treated with veptr surgery beginning at <10 years of age.All complications data: 17 subjects experienced fatal complications, with zero related to veptr devices.17 sae death.1 sae -death -pneumonia secondary to covid-19.3 sae- death ¿ respiratory complications.2 sae- death -chronic respiratory failure.2 sae- death- cardio- respiratory arrest.1 sae death-extended seizure.1 sae death- tracheal exsanguination.1 sae death- septic shock.6 sae death- unknown/died in sleep.Sae-surgical intervention.6 intraoperative (other complications).(n=174 study patients).325 implant related complications , resolved by surgical intervention.182 implant related complications : surgical intervention, (n=325) ¿ planned surgery.143 implant related complications : surgical intervention, (n=325) ¿unplanned surgery.Other complication: 63 pain.2 medical.287 wound related.12 neurologic injury/impairment.3 pseudarthrosis.84 pulmonary.183 other.Implant related complications (n=174 study patients): 329 implant related complications.293 implant related complications ,yes device related.36 implant related complications ,uncertain if device related.149/17 implant related complications (n=329) migration (no.Yes | no.Uncertain).103/0 implant related complications (n=329) broken rods (no.Yes | no.Uncertain).10/12 implant related complications (n=329) -dislodged hardware (no.Yes | no.Uncertain).21/3 implant related complications (n=329) anchor prominence (no.Yes | no.Uncertain).6/0 implant related complications (n=329) exposed hardware (no.Yes | no.Uncertain).4/4 implant related complications (n=329)-skin erosion (no.Yes | no.Uncertain).This is for depuy synthes veptr and veptr ii.A copy of the clinical evaluation form is being submitted with this regulatory report.This report is for one (1) unk - constructs: veptr.This is report 4 of 16 for complaint (b)(4).

• Brand Name: UNK - CONSTRUCTS: VEPTR II
• Type of Device: PROSTHESIS, RIB REPLACEMENT
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 12488691
• MDR Text Key: 282325120
• Report Number: 2939274-2021-05501
• 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
• Type of Report: Initial,Followup
• Report Date: 08/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/17/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/23/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention