Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOBIOLOGICS-MALVERN 5CC CARTRIDGE; POLYMETHYLMETHACRYLATE (PMMA) BONE CEMENT
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

STRYKER ORTHOBIOLOGICS-MALVERN 5CC CARTRIDGE; POLYMETHYLMETHACRYLATE (PMMA) BONE CEMENT Back to Search Results
Catalog Number 2101-0005
Device Problem Device Operates Differently Than Expected (2913)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/03/2015
Event Type  malfunction  
Event Description
It was reported that; the sales rep reports that during the procedure that he was sitting in on - when introducing cement into the patient, the material set within approximately 30 seconds, as opposed to the usual time.They attempted to use a second unit and the same issued happened with that as well.
 
Manufacturer Narrative
Method: visual inspection; functional inspection; device history review; complaint history review; risk assessment; results: device history review indicated all devices accepted into final stock met specifications.Per additional email correspondence; it was reported that the product was allowed to equilibrate to room temperature prior to use for 45min, the product was stored in standard refrigerator temp (45f) and room was 69 degrees.Sales rep also indicated that the product was not injected into the mixtip and sitting for any period of time prior to injection.Conclusion: the plausible root cause for the reported event is multifactorial.
 
Event Description
It was reported that; the sales rep reports that during the procedure that he was sitting in on - when introducing cement into the patient, the material set within approximately 30 seconds, as opposed to the usual time.They attempted to use a second unit and the same issued happened with that as well.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
5CC CARTRIDGE
Type of Device
POLYMETHYLMETHACRYLATE (PMMA) BONE CEMENT
Manufacturer (Section D)
STRYKER ORTHOBIOLOGICS-MALVERN
45 great valley parkway
malvern PA 19355
Manufacturer (Section G)
STRYKER ORTHOBIOLOGICS-MALVERN
45 great valley parkway
malvern PA 19355
Manufacturer Contact
christa marrow
2 pearl court
allendale, NJ 07401
2017608000
MDR Report Key5330540
MDR Text Key35031767
Report Number0002530131-2015-00023
Device Sequence Number1
Product Code NDN
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 12/03/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/28/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Catalogue Number2101-0005
Device Lot NumberA1506068
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/29/2016
Is the Reporter a Health Professional? No
Date Manufacturer Received12/03/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/22/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
-
-