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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AMENDIA SAVANNAH-T PEDICLE SCREW DRIVER

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AMENDIA SAVANNAH-T PEDICLE SCREW DRIVER Back to Search Results
Model Number SP-0434
Device Problem Device Issue (2379)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 09/19/2016
Event Type  Malfunction  
Manufacturer Narrative

This device is not a standard instrument for this system. The driver did not retain the screw which led to a delay in surgery. There was no impact to the patient, but if the driver does not retain the screw properly it could fall off in wound; the chance is not remote that if this were to happen again it would lead to injury.

 
Event Description

Driver did not retain screw; no adverse consequence to the patient.

 
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Brand NameSAVANNAH-T
Type of DevicePEDICLE SCREW DRIVER
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 Key6042022
MDR Text Key57923862
Report Number1067096-2016-00026
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 09/20/2016
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received10/19/2016
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator
Device MODEL NumberSP-0434
Device LOT Number136793
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 Received09/20/2016
Was Device Evaluated By Manufacturer? Yes
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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