MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH VERTECEM V+ CEMENT KIT; POLYMETHYLMETHACRYLATE BONE CEMENT

Catalog Number 07.702.016S

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Stroke/CVA (1770); Paralysis (1997); Blood Loss (2597)

Event Type  Injury  

Manufacturer Narrative

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

Device report from synthes reports an event in (b)(6) as follows: it was reported that on an unknown date, the patient underwent a secondary operation to stop the bleeding and to remove the leaked vertecem v cement.Initially, the patient had a vertebroplasty and was applied two (2) vertecem v+ cement kit on (b)(6) 2019 for osteoporotic fracture of the vertebral body.According to the facility staff, the operation went smooth for nine (9) levels of vertebroplasty and the surgeon did not have any complaint with the products and the cement during the operation.After the primary surgery, the patient had spinal bleeding, stroke, paralyzed, and was under investigation.The patient has a bleeding tendency and some cement leaked into the spinal canal.During re-operation, the surgeon removed some cement which have been leaked to the spinal canal.The procedure was completed without any issues.There was no surgical delay reported.Subsequently, the patient was stable and was sent for follow-up.Concomitant device reported: vertebroplasty needle kit, 8-gauge ( part# 03.702.216s, lot# asa162, quantity 2), vertebroplasty needle kit, 8-gauge ( part# 03.702.216s, lot# aqf444, quantity 1), vertebroplasty needle kit, 10-gauge ( part# 03.702.218s, lot# ase302, quantity 1); vertebroplasty needle kit, 10-gauge ( part# 03.702.218s, lot# asf038, quantity 3); vertebroplasty needle kit, 12-gauge ( part# 03.702.221s, lot# art219, quantity 1); vertebroplasty needle kit, 12-gauge ( part# 03.702.221s, lot# asc843, quantity 1); vertecem v+ syringe kit ( part# 03.702.221s, lot# 8052501, quantity 1), vertecem v+ syringe kit ( part# 03.702.221s, lot# 8102588, quantity 1).This report is for one (1) vertecem v+ cement kit.This is report 2 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.Part: 07.702.016s.Lot: 8g53250.Manufacturing site: selzach.Supplier: osartis gmbh.Release to warehouse date: 28.Nov.2018.Expiry date: 01.Jul.2021.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.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: VERTECEM V+ CEMENT KIT
• Type of Device: POLYMETHYLMETHACRYLATE BONE CEMENT
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 8743674
• MDR Text Key: 149488063
• Report Number: 8030965-2019-65841
• Device Sequence Number: 1
• Product Code: NDN
• UDI-Device Identifier: 07611819376250
• UDI-Public: (01)07611819376250
• Combination Product (y/n): N
• PMA/PMN Number: K090432
• 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: 06/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/01/2021
• Device Catalogue Number: 07.702.016S
• Device Lot Number: 8G53250
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/12/2019
• Patient Sequence Number: 1
• Treatment: VERTEBROPLASTYNEEDLE KIT 10-GAUGE CANNUL; VERTEBROPLASTYNEEDLE KIT 10-GAUGE CANNUL; VERTEBROPLASTYNEEDLE KIT 10-GAUGE CANNUL; VERTEBROPLASTYNEEDLE KIT 10-GAUGE CANNUL; VERTEBROPLASTYNEEDLE KIT 12-GAUGE CANNUL; VERTEBROPLASTYNEEDLE KIT 12-GAUGE CANNUL; VERTEBROPLASTYNEEDLE KIT 8-GAUGE CANNULA; VERTEBROPLASTYNEEDLE KIT 8-GAUGE CANNULA; VERTEBROPLASTYNEEDLE KIT 8-GAUGE CANNULA; VERTECEM V+ SYRINGE KIT; VERTECEM V+ SYRINGE KIT; VERTEBROPLASTYNEEDLE KIT 10-GAUGE CANNUL; VERTEBROPLASTYNEEDLE KIT 10-GAUGE CANNUL; VERTEBROPLASTYNEEDLE KIT 10-GAUGE CANNUL; VERTEBROPLASTYNEEDLE KIT 10-GAUGE CANNUL; VERTEBROPLASTYNEEDLE KIT 12-GAUGE CANNUL; VERTEBROPLASTYNEEDLE KIT 12-GAUGE CANNUL; VERTEBROPLASTYNEEDLE KIT 8-GAUGE CANNULA; VERTEBROPLASTYNEEDLE KIT 8-GAUGE CANNULA; VERTEBROPLASTYNEEDLE KIT 8-GAUGE CANNULA; VERTECEM V+ SYRINGE KIT; VERTECEM V+ SYRINGE KIT
• Patient Outcome(s): Required Intervention
• Patient Age: 63 YR