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

Catalog Number 07.702.016S

Device Problems Device Difficult to Setup or Prepare (1487); Device Difficult to Maintain (3134)

Patient Problem No Patient Involvement (2645)

Event Date 04/15/2019

Event Type  malfunction  

Manufacturer Narrative

Lot and expiration date is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.Occupation: synthes sales rep.510(k) - pending clearance.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 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 that during an anterior & posterior lumbar fusion/fixation procedure on (b)(6) 2019, three (3) loads of vertecem v+ cement kit did not work where cement did not come out.There was 20 minutes surgical delay reported.The procedure was successfully completed.The patient condition was good.This complaint involves three (3) devices.This report is for one (1) vertecem v+ cement kit.This report is 3 of 3 for (b)(4).

Event Description

It was reported that during an anterior & posterior lumbar fusion/fixation procedure on (b)(6) 2019, three (3) loads of vertecem v+ cement kit did not work well where it does not give the amount of cement that should come out.A small amount of cement was implanted to the patient using the 3 units of vertecem.There was 20 minutes surgical delay reported.The procedure was successfully completed.The patient condition was good.

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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.Additional narrative: updated event description.Postal code device is not distributed in the united states, but is similar to device marketed in the usa.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: 8613910
• MDR Text Key: 145389087
• Report Number: 8030965-2019-63997
• Device Sequence Number: 1
• Product Code: NDN
• UDI-Device Identifier: 07611819376250
• UDI-Public: (01)07611819376250
• 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: 04/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 07.702.016S
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/16/2019
• Initial Date FDA Received: 05/15/2019
• Supplement Dates Manufacturer Received: 05/23/2019
• Supplement Dates FDA Received: 06/19/2019
• Patient Sequence Number: 1