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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES (USA) VERTEBRAL SPACER-CR LORDOTIC 8MM VERTEBRAL SPACERS

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SYNTHES (USA) VERTEBRAL SPACER-CR LORDOTIC 8MM VERTEBRAL SPACERS Back to Search Results
Catalog Number 889.924
Event Date 01/30/2006
Event Type  Malfunction  
Event Description

A vertebral spacer-cr lordotic 8mm corner started to break off/fracture during implantation. Implant was retrieved without complication and another was successfully used.

 
Manufacturer Narrative

H3, h6: subject device has been received and is currently in the evaluation process. No conclusion can be drawn at this time.

 
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Brand NameVERTEBRAL SPACER-CR LORDOTIC 8MM
Type of DeviceVERTEBRAL SPACERS
Baseline Brand NameVERTEBRAL SPACER-CR LORDOTIC 8MM
Baseline Generic NameVERTEBRAL SPACERS
Baseline Catalogue Number889.924
Manufacturer (Section F)
SYNTHES (USA)
west chester PA 19380
Manufacturer (Section D)
SYNTHES (USA)
west chester PA 19380
Manufacturer (Section G)
SYNTHES, USA
1303 goshen parkway
west chester PA 19880
Manufacturer Contact
jody temple
1302 wrights lane east
west chester , PA 19380
(800) 620 -7025
Device Event Key669394
MDR Report Key680123
Event Key647094
Report Number2530088-2006-00012
Device Sequence Number1
Product CodeMQP
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 01/30/2006
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/24/2006
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number889.924
Device LOT Number5080060
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer02/08/2006
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received01/30/2006
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured09/01/2005
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Is the Device an Implant? Yes
Is this an Explanted Device?
Type of Device Usage Unkown

Patient TREATMENT DATA
Date Received: 02/24/2006 Patient Sequence Number: 1
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