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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AMENDIA SAVANNAH-T PEDICLE SCREW SPINAL SYSTEM

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AMENDIA SAVANNAH-T PEDICLE SCREW SPINAL SYSTEM Back to Search Results
Model Number 10-21-6545-1
Device Problem Fracture (1260)
Patient Problem No Code Available (3191)
Event Date 11/28/2016
Event Type  Injury  
Manufacturer Narrative

This failure occurred over 3 years post-op; fusion likely occurred, but failure led to additional revision surgery which would classify this event as a serious injury per fda draft guidance. Date of initial surgery listed as (b)(6) 2013, however please note the exact day in 2013 is not known; esubmitter will not allow to enter only the year of the event, therefore (b)(6) was entered.

 
Event Description

Screw fracture requiring revision surgery.

 
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Brand NameSAVANNAH-T
Type of DevicePEDICLE SCREW SPINAL SYSTEM
Manufacturer (Section D)
AMENDIA
1755 west oak parkway
marietta GA 30062
Manufacturer (Section G)
AMENDIA
1755 west oak parkway
marietta GA 30062
Manufacturer Contact
bruce hooper
1755 west oak parkway
marietta, GA 30062
8777553329
MDR Report Key6208764
MDR Text Key63405322
Report Number1067095-2016-00032
Device Sequence Number1
Product Code NKB
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK152920
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type DISTRIBUTOR
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial
Report Date 12/28/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/28/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator
Device MODEL Number10-21-6545-1
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/28/2016
Was Device Evaluated By Manufacturer? Yes
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 12/28/2016 Patient Sequence Number: 1
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