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

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Failure of Implant (1924)

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.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 veptr implants: superior cradle/unknown lot.Part and lot number are unknown.Without the specific part number; the udi number and 510-k 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.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

Device report from synthes reports an event in the united kingdom as follows: this report is being filed after the review of the following journal article: dong h., et al (2021) efficacy of distal pedicle screw fixation as a caudal foundation in veptr growing rod constructs for early onset scoliosis, spine deformity volume 9: pages 1169¿1174 (united kingdom).This study aims to evaluate the efficacy of the distal pedicle screw-based construct in patients with a proximal rib-based claw.Between 2007 and 2017, patients with early onset scoliosis (eos) were treated with the vertical expandable titanium prosthetic rib (veptr) implant (depuy synthes, raynham ma, usa) prosthesis and a pedicle screw-based distal foundation was evaluated.A total of 15 patients were analyzed with a male to female ratio of 2:1.Average age at the time of index surgery was 4 years and 10 months (2y 4 m¿12y 1 m).The majority of patients (11) had unilateral constructs, and the remainder were augmented with bilateral distal pedicle screws at the same contiguous levels.The mean radiographic follow-up period was 7 years and 2 months (3y 10 m¿9y 11 m).Reported complications: there were six patients who underwent surgical revisions -4 proximal cradle cut-out.- 1 failure to control curve.- 1 adjacent decompensating curve.-1 rod fracture.This report is for an unknown synthes vertical expandable titanium prosthetic rib (veptr) implant.This is report 1 of 3 for (b)(4).

• Brand Name: UNK - VEPTR IMPLANTS: SUPERIOR CRADLE
• 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: 15334752
• MDR Text Key: 299049311
• Report Number: 8030965-2022-06234
• Device Sequence Number: 1
• Product Code: MDI
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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

• Date FDA Received: 09/01/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• 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