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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY SYNTHES SPINE JAGUAR CAGE; SPINAL PEDICLE SCREW, FIXATION, APPLIANCE SYSTEM
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DEPUY SYNTHES SPINE JAGUAR CAGE; SPINAL PEDICLE SCREW, FIXATION, APPLIANCE SYSTEM Back to Search Results
Device Problem Positioning Problem (3009)
Patient Problem No Code Available (3191)
Event Type  Injury  
Event Description
Post market surveillance: jaguar; cage subsidence.Does alendronate disturb the healing process of posterior lumbar interbody fusion? a prospective randomized trial (nagahama, k.) publication date: apr 2011.N=6 cage subsidence.
 
Manufacturer Narrative
No follow up report is anticipated as the product has not been returned.The source of the report is the following literature source: ¿does alendronate disturb the healing process of posterior lumbar interbody fusion? a prospective randomized trial (nagahama, k.) publication date: apr 2011¿.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Device not returned.
 
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Brand Name
JAGUAR CAGE
Type of Device
SPINAL PEDICLE SCREW, FIXATION, APPLIANCE SYSTEM
Manufacturer (Section D)
DEPUY SYNTHES SPINE
325 paramount drive
raynham MA 02767
Manufacturer (Section G)
DEPUY SYNTHES SPINE
325 paramount drive
raynham MA 02767
Manufacturer Contact
anita barnick
325 paramount drive
raynham, MA 02767
5088283583
MDR Report Key3863534
MDR Text Key4505409
Report Number1526439-2014-11601
Device Sequence Number1
Product Code MCV
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Literature,Company Representative
Type of Report Initial
Report Date 05/21/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/10/2014
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Physician
Was Device Available for Evaluation? No
Event Location Hospital
Date Manufacturer Received05/21/2014
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? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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