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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES GMBH VERTECEM V+ CEMENT KIT; CEMENT, BONE, VERTEBROPLASTY

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SYNTHES GMBH VERTECEM V+ CEMENT KIT; CEMENT, BONE, VERTEBROPLASTY Back to Search Results
Catalog Number 07.702.016S
Device Problems Improper Chemical Reaction (2952); Failure to Eject (4010)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/05/2023
Event Type  malfunction  
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.H10 additional narrative: d9: complainant part is not expected to be returned for manufacturer review/investigation.E1: initial reporter facility name: (b)(6) hospital.E3: reporter is a j&j employee.G4: device is not distributed in the united states, but is similar to device marketed in the usa.H3, h4, h6: 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 history review (dhr): part # 07.702.016s.Lot # 3b53590.Manufacturing site: werk selzach.Release to warehouse date: 03.Feb.2023.Expiration date: 01.Feb.2026.Supplier: osartis gmbh.A manufacturing record evaluation was performed for the finished article lot 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.
 
Event Description
Device report from synthes reports an event in japan as follows: it was reported that on (b)(6) 2023, the surgeon tried mixing the cement in question after adding all the liquid, but the handle did not move at all.He always moves the handle at a slight angle, but this time the handle did not move at all, so a spare product was used.Regarding the spare cement in question, the surgeon spilled a little liquid, which resulted in the cement with less moisture than usual, and when filling the syringe, it was very hard and not much cement came out.The patient outcome was reported to be stable.This report involves one vertecem v+ cement kit.This is report 2 of 2 for (b)(4).
 
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Brand Name
VERTECEM V+ CEMENT KIT
Type of Device
CEMENT, BONE, VERTEBROPLASTY
Manufacturer (Section D)
SYNTHES GMBH
eimattstrasse 3
oberdorf 4436
SZ  4436
Manufacturer (Section G)
SYNTHES SELZACH
bohackerweg 5
selzach 2545
SZ   2545
Manufacturer Contact
kate karberg
1302 wright lane east
west chester, PA 19380
3035526892
MDR Report Key18399871
MDR Text Key331488873
Report Number8030965-2023-16193
Device Sequence Number1
Product Code NDN
UDI-Device Identifier07611819376250
UDI-Public(01)07611819376250
Combination Product (y/n)N
Reporter Country CodeJA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial
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
Device Lot Number3B53590
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 12/05/2023
Initial Date FDA Received12/27/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/03/2023
Is the Device Single Use? Yes
Type of Device Usage Unknown
Removal/Correction NumberN/A
Patient Sequence Number1
Treatment
VERTECEM V+ CEMENT KIT
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