MAUDE Adverse Event Report: SYNTHES GMBH UNK - SYNFLATE/VBS; CEMENT, BONE, VERTEBROPLASTY

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

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 vbs system/unknown lot.Part and lot number are unknown.Without the specific part number; the udi number and 510-k number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.(b)(4).Without a lot number the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.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 78 patients with 26 females and 52 males (mean age, 61 ± 14 [21 - 90] years; 66.7% female) undergoing vbs procedures for traumatic, osteoporotic, or metastatic thoracolumbar compression fractures between 01/2012 and 12/2020 were included in the study.Minimum follow-up period was 6 months after surgery.Polymethylmethacrylate (pmma) cement (vertecem v+, depuy synthes, raynham, ma, usa) was injected bilaterally into the stent cavities.Intraoperative complications - (material failure -(n=2) therein no stent deployment could be seen -(n=2) insufficient ballooning (was defined as a bursted balloon or leaking contrast agent despite compliance with the maximum permitted filling volume and pressure.) radiographic complications - vbs dislocation or cut out -(n=3) cut out.(any stent laying at any part outside of the vertebral cortical border was taken into account for a stent-cut-out).Radiographic complications - cement leakage - no vascular leakage reported -33 (none of the cement leakages had a clinically relevant consequence requiring further treatment.) -(n=21) patients with cement leakage into the anterolateral, paravertebral region.-(n=11) patients with intradiscal cement leakage.-(n=1) patient with posterior cement leakage into the spinal canal.Radiographic complications -(n=1) adjacent segment fracture.Clinical complications -revision surgery (n=1) revision surgery.The patient developed potential procedure related spondylodiscitis with subsequent bone necrosis at the vbs level 5 months after index surgery.Therefore, a subtotal corporectomy with cage replacement, disc biopsy and posterior instrumentation was performed.This is for depuy synthes vbs system.This report captures the reported event of vbs dislocation or cut out.This is report 2 of 6 for (b)(4).

• Brand Name: UNK - SYNFLATE/VBS
• Type of Device: CEMENT, BONE, VERTEBROPLASTY
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kate karberg ; 1302 wrights lane east; west chester, PA 19380 ; 8472871282
• MDR Report Key: 14641103
• MDR Text Key: 294779633
• Report Number: 8030965-2022-03821
• Device Sequence Number: 1
• Product Code: NDN
• Combination Product (y/n): N
• Reporter Country Code: SZ
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2022
• 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: 05/11/2022
• 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