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

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

Patient Problem Insufficient Information (4580)

Event Type  Injury  

Event Description

Device report from synthes reports an event in canada as follows: this report is being filed after the review of the following journal article: bowker r, et al.(2022), scoliosis flexibility correlates with post operative outcomes following growth friendly surgery, spine deformity (2022) 10:933¿941 https://doi.Org/10.1007/s43390-022-00481-0 (usa).The purpose of this study was to determine the relationship between pre-operative scoliosis flexibility and postoperative outcomes, including curve correction and complications, for patients who have been treated with growth friendly surgery (gfs) for early onset scoliosis (eos).The study was conducted as a retrospective review of prospectively collected data from an international, multicenter, early onset scoliosis database.Early onset scoliosis patients with pre-operative flexibility radiographs (traction or bending) were identified 107 patients (14 congenital, 43 neuromuscular, 31 syndromic, 19 idiopathic) with mean age 7.1 years at index surgery were included in the study.There were 14 patients who received the unknown synthes vertical expandable prosthetic titanium rib (veptr) implant, 39 patients who received an unknown manufacturer magnetic growing rods and 54 patients who received an unknown manufacturer traditional growing rod.Complications were reported as follows: 13 patients had unspecified complications.For the entire study, 71 percent of complications were classified as mcds type iii, which demonstrates that resolution of most complications required either unplanned surgery or an unplanned hospital admission.5 percent of complications were considered to be life-threatening or require icu admission, while 36 percent required unplanned return to the operating room.This report involves one unk - constructs: veptr.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/unknown lot.Part and lot numbers are unknown; udi 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
• 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: 15393405
• MDR Text Key: 299595573
• Report Number: 8030965-2022-06591
• Device Sequence Number: 1
• Product Code: MDI
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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: 09/09/2022
• 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: 08/17/2022
• 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