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

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Failure of Implant (1924); Unspecified Infection (1930); Pain (1994)

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.This report is for an unknown constructs: veptr/unknown lot number.Without the specific part number, the udi number and 510k number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.(b)(6).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 saudi arabia as follows: this report is being filed after the review of the following journal article: majid ob, et al.(2021), radiological outcomes and complications of vertical expandable titanium rib instrumentation in congenital scoliosis with or without rib fusion: a retrospective study, cureus 13(3): e14167.Doi 10.7759/cureus.14167, (saudi arabia).This study aimed to evaluate the radiological outcome of vertical expandable titanium rib application after follow-up in children with congenital scoliosis with or without rib fusion.From 2005 to 2015, 58 patients with congenital scoliosis with or without fused ribs treated with vertical expandable titanium rib were included in the study.There were 19 males and 39 females with a mean age of 5.95 years (range, 1 year 3 months to 14 years).All patients were implanted with an unknown synthes vertical expandable prosthetic titanium rib (veptr).The average number of expansion procedures was 4.26 (range, 1-9).The mean duration of follow-up was 5 years (range, 2-12 years).28 patients had rib-to-pelvis type veptr, 20 patients had rib-to-rib type veptr, and 10 patients had a rib to pedicle/lamina type of veptr implant.Complications were reported as follows: 12 patients had implant migration which were revised in the subsequent lengthening procedure.9 patients had severe hardware prominence.6 patients had skin infection and pain.4 patients had deep infection.2 were treated with irrigation, debridement, and iv antibiotics, without the removal of the implant.The implant was removed prematurely in the remaining 2 cases.This report is for the unknown synthes vertical expandable prosthetic titanium rib (veptr).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 - CONSTRUCTS: VEPTR
• Type of Device: PROSTHESIS, RIB REPLACEMENT
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kate karberg ; eimattstrasse 3; oberdorf ; SZ ; 6103142063
• MDR Report Key: 15330077
• MDR Text Key: 299043068
• Report Number: 8030965-2022-06198
• Device Sequence Number: 1
• Product Code: MDI
• Combination Product (y/n): N
• Reporter Country Code: SA
• 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: 08/31/2022
• 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: 08/08/2022
• 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