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U.S. Department of Health and Human Services

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

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OBERDORF SYNTHES PRODUKTIONS GMBH VERTECEM V+ CEMENT KIT; POLYMETHYLMETHACRYLATE BONE CEMENT Back to Search Results
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.
 
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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 Key8613910
MDR Text Key145389087
Report Number8030965-2019-63997
Device Sequence Number1
Product Code NDN
UDI-Device Identifier07611819376250
UDI-Public(01)07611819376250
Combination Product (y/n)N
Number of Events Reported1
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 Number07.702.016S
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 04/16/2019
Initial Date FDA Received05/15/2019
Supplement Dates Manufacturer Received05/23/2019
Supplement Dates FDA Received06/19/2019
Patient Sequence Number1
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