• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES USA TRAUMACEM V+CEMENT 10ML KIT STERILE POLYMETHYLMETHACRYLATE 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
 

SYNTHES USA TRAUMACEM V+CEMENT 10ML KIT STERILE POLYMETHYLMETHACRYLATE BONE CEMENT Back to Search Results
Catalog Number 07.702.040S
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Impaired Healing (2378)
Event Date 01/08/2016
Event Type  Injury  
Manufacturer Narrative
Additional narrative: patient age/date of birth is unknown; year of birth reported as 1941. Patient weight is unknown. Date of event reported as (b)(6) 2016; it is unknown if that is when the loss of reduction occurred or when it was noticed. This report is for an unknown cement kit/unknown lot. Part and lot numbers are unknown; udi number is unknown. Complainant part is not expected to be returned for manufacturer review/investigation. (b)(6). Without a lot number the device history records review could not be completed. The investigation could not be completed; no conclusion could be drawn, as no product was received. 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 (b)(4) reports an event in (b)(6) as follows: clinical study case: it was reported that loss of reduction occurred, which was corrected by revision to reverse total shoulder arthroplasty. The revision took place on (b)(6) 2016. The philos implants were implanted on (b)(6) 2015. This report is for an unknown cement kit. This is report 3 of 3 for (b)(4).
 
Manufacturer Narrative
Device is not distributed in the united states, but is similar to device marketed in the usa. (b)(4). Initially reported as (b)(6) 2016; should be (b)(6) 2016. 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
This is report 3 of 10 for (b)(4).
 
Manufacturer Narrative
Initially reported device product code and common name (ndn, polymethylmethacrylate bone cement) was correct. 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.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameTRAUMACEM V+CEMENT 10ML KIT STERILE
Type of DevicePOLYMETHYLMETHACRYLATE BONE CEMENT
Manufacturer (Section D)
SYNTHES USA
1302 wrights lane east
west chester PA 19380
Manufacturer Contact
linda plews
1302 wrights lane east
west chester, PA 19380
6107195000
MDR Report Key5454396
MDR Text Key38808054
Report Number2520274-2016-11229
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 company representative,foreig
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 02/09/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/23/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number07.702.040S
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/31/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 02/23/2016 Patient Sequence Number: 1
-
-