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

Device Problem Material Integrity Problem (2978)

Patient Problem Failure of Implant (1924)

Event Type  Injury  

Event Description

Device report from synthes reports an event in jordan as follows: this report is being filed after the review of the following journal article: almajali, a.Et al (2020), early childhood scoliosis management by vertical expandable prosthetic titanium rib (veptr): experience of royal medical services (rms), medical archives, vol.74 (5), pages 433-438 (jordan).The aim of this retrospective analysis of prospectively collected data of case series study is to show experience and results regarding the use of veptr in children with scoliosis in regard to coronal profiles (length and deformity angle), spinal growth, and the complications the authors¿ faced during the follow-up of two years after the index procedure.Between january 2016 to january 2018, a total of 40 patients (14 male and 26 female) with an average age of 5.4 (4.1 to 7.9) years were included in the study.Surgery was performed using the vertical expandable prosthetic titanium rib (veptr).All of them had completed 2-year follow-up at the time of data analysis.The following complications were reported as follows: 10 patients had fractured rib and cut through of the proximal hock or ring managed by repositioning procedure not counted in the total number of distractions.2 patients had migration of the iliac hock managed by repositioning of the hock and the procedure is not counted in distractions.2 patients had breakage of the railway end of the sliding bar, which managed by sliding bar exchange.4 patients had superficial infection and wound dehiscence: three of them managed and did very well, and unfortunately one of them developed deep infection which mandate removal of the implant, and this case was not excluded from our study group because he was almost 23 months post index procedure when infection developed.This report is for an unknown synthes veptr.This is report 3 of 3 for complaint (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.This report is for an unk - veptr implants/unknown lot number.Without the specific part number, the udi number and 510k number is unknown.Device available for evaluation: complainant part is not expected to be returned for manufacturer review/investigation.Postal code (b)(4).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.

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.D1, d2, d3, d4, g4 510k: this report is for an unk - rod: veptr/unknown lot number.Without the specific part number, the udi number and 510k number is unknown.Product was not returned.Based on the information available, it has been determined that no corrective and 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 if information is obtained that was not available for this medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: UNK - RODS: 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: 15329185
• MDR Text Key: 299001987
• Report Number: 8030965-2022-06193
• Device Sequence Number: 1
• Product Code: MDI
• Combination Product (y/n): N
• Reporter Country Code: JO
• 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?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/08/2022
• Initial Date FDA Received: 08/31/2022
• Supplement Dates Manufacturer Received: 09/29/2022
• Supplement Dates FDA Received: 09/30/2022
• 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