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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY-SYNTHES SPINE CONFIDENCE SPINAL CEMENT SYSTEM; CEMENT, BONE, VERTEBROPLASTY
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DEPUY-SYNTHES SPINE CONFIDENCE SPINAL CEMENT SYSTEM; CEMENT, BONE, VERTEBROPLASTY Back to Search Results
Catalog Number UNK-CEMENT/CEM ACCESORY
Device Problem Filling Problem (1233)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/09/2017
Event Type  malfunction  
Manufacturer Narrative
A supplemental report is not anticipated unless the results of the complaint investigation identify a corrective action or additional relevant information.Should the product become available, a physical evaluation will be conducted and a supplemental report filed with the results.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Device not returned.
 
Event Description
Surgeon realizes different properties of cement than he is used to.(b)(4).
 
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Brand Name
CONFIDENCE SPINAL CEMENT SYSTEM
Type of Device
CEMENT, BONE, VERTEBROPLASTY
Manufacturer (Section D)
DEPUY-SYNTHES SPINE
325 paramount drive
raynham MA 02767
Manufacturer (Section G)
MEDOS INTERNATIONAL SARL
chemin blanc 38
le locle CH-24 00
SZ   CH-2400
Manufacturer Contact
jason busch
325 paramount drive
raynham, MA 02767
5088808201
MDR Report Key6718455
MDR Text Key80206243
Report Number1526439-2017-10592
Device Sequence Number1
Product Code NDN
Combination Product (y/n)N
Reporter Country CodeSZ
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Physician
Type of Report Initial
Report Date 06/06/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/17/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Physician
Device Catalogue NumberUNK-CEMENT/CEM ACCESORY
Is the Reporter a Health Professional? Yes
Date Manufacturer Received06/06/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Type of Device Usage N
Patient Sequence Number1
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