MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH VERTEBRAL BODY STENT-SMALL; POLYMETHYLMETHACRYLATE BONE CEMENT

Catalog Number 09.804.500S

Device Problem Migration (4003)

Patient Problem No Patient Involvement (2645)

Event Date 07/09/2020

Event Type  malfunction  

Manufacturer Narrative

Complainant part is expected to be returned for manufacturer review/investigation but has yet to be received.The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.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 (b)(6) as follows: it was reported on an unknown date that the patient was underwent for a double level vertebroplasty in the lumbar spine.The left stent on the superior level was expanded and he began to expand the stent on the right, upon imaging (lateral) the stent ended up expanded anterior to the vertebral body.The surgeon immediately released the pressure and removed the catheter.Upon taking an ap image the stent looked lateral to the vb.The procedure was completed of cementing for the left sided stents.The patient was immediately sent for a ct to determine the position of the stent relative to the internal organs/ vessels to determine if a second surgery would be required to remove the stent.The patient will need revision surgery.The patient outcome was unknown.This complaint involves one (1) device.This report is for (1) vertebral body stent-small.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.H3, h4, h6: part number: 09.804.500s, lot number: 0917053, manufacturing site: selzach, supplier: (b)(4), release to warehouse date: 03.Nov.2017, expiry date: 01.Oct.2020.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.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: VERTEBRAL BODY STENT-SMALL
• Type of Device: POLYMETHYLMETHACRYLATE BONE CEMENT
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 10352882
• MDR Text Key: 201583715
• Report Number: 8030965-2020-05547
• Device Sequence Number: 1
• Product Code: NDN
• UDI-Device Identifier: 07611819432604
• UDI-Public: (01)07611819432604
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 07/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/31/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/01/2020
• Device Catalogue Number: 09.804.500S
• Device Lot Number: 0917053
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/13/2020
• Patient Sequence Number: 1