MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH UNK - SYNFLATE/VBS; POLYMETHYLMETHACRYLATE BONE CEMENT

Device Problem Migration (4003)

Patient Problems Failure of Implant (1924); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Multiple patient involved.This report is for an unk - synflate/vbs /unknown lot.Part and lot numbers are unknown; udi number is unknown.Without a lot number, the device history records review could not be completed as no product was received.The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.(b)(4).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 switzerland reports an event as follows: this report is being filed after the review of the following journal article: venier a, et al.(2019), armed kyphoplasty: an indirect central canal decompression technique in burst fractures, ajnr am j neuroradiology, volume 40, page 1965-1972, (switzerland).This study retrospectively assessed the results of armed kyphoplasty using vertebral body stents or spine jack, with or without posterior instrumentation, in traumatic, osteoporotic, and neoplastic burst fractures with regard to correction of posterior wall retropulsion and restoration of vertebral body height.Between august 2013 and december 2017, 51 patients (53 burst fractures with posterior wall retropulsion and no neurologic deficit) who were treated with armed kyphoplasty were included in the study.Armed kyphoplasty was performed with and unknown synthes vertebral body stents at 46/53 levels and with a competitor¿s device at 7/53 levels.Complications were reported as follows: 1 patient had transient and completely reversible paraparesis, without evidence of worsening central canal compromise and without epidural cement leaks on postprocedure computed tomography and magnetic resonance imaging.6 patients had worsened posterior wall retropulsion postoperatively.2 patients had reduced vertebral body height at postprocedure computed tomography scan.19 patients had mild subsidence of the superior or inferior endplates with no convincing impact on alignment and kyphosis at follow-up.3 patients had a recurrent vertebral body height collapse of the target level at follow-up.8 patients had a recurrence of posterior wall retropulsion.2 of these were associated with refracture of the target level, while 6 were associated with subsidence of the treated vertebra at follow-up.This report is for the unknown synthes vertebral body stents.This is report 1 of 2 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.H3, h4, h6: 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.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.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 - SYNFLATE/VBS
• Type of Device: POLYMETHYLMETHACRYLATE BONE CEMENT
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 10568232
• MDR Text Key: 208326061
• Report Number: 8030965-2020-07319
• Device Sequence Number: 1
• Product Code: NDN
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Type of Report: Initial,Followup
• Report Date: 09/09/2020

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
• Initial Date Manufacturer Received: 09/09/2020
• Initial Date FDA Received: 09/22/2020
• Supplement Dates Manufacturer Received: 09/29/2020
• Supplement Dates FDA Received: 10/20/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention