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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ALPHATEC SPINE, INC ALPHATEC NAVIGATION INSTRUMENTS ORTHOPEDIC STEREOTAXIC INSTRUMENT

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ALPHATEC SPINE, INC ALPHATEC NAVIGATION INSTRUMENTS ORTHOPEDIC STEREOTAXIC INSTRUMENT Back to Search Results
Model Number 17140
Device Problem Fracture (1260)
Patient Problem Insufficient Information (4580)
Event Date 11/01/2021
Event Type  malfunction  
Manufacturer Narrative
The returned instrument is currently being evaluated. A follow up report with results of the investigation will be submitted upon completion.
 
Event Description
The distal tip of an invictus navigation screwdriver sheared off. There is no report of patient involvement.
 
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Brand NameALPHATEC NAVIGATION INSTRUMENTS
Type of DeviceORTHOPEDIC STEREOTAXIC INSTRUMENT
Manufacturer (Section D)
ALPHATEC SPINE, INC
1950 camino roble vida
carlsbad CA 92008
Manufacturer Contact
wesley channell
1950 camino vida roble
carlsbad, CA 92008
9014283693
MDR Report Key12902314
MDR Text Key282823185
Report Number2027467-2021-00077
Device Sequence Number1
Product Code OLO
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K153603
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 11/02/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/30/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Model Number17140
Device Catalogue Number17140
Device Lot Number8729901
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/03/2021
Date Manufacturer Received11/02/2021
Was Device Evaluated by Manufacturer? No
Date Device Manufactured02/25/2021
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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