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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ALPHATEC SPINE, INC OSSEOSCREW OSSEOSCREW F TI HIGH TOP 6.5 X 50MM

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ALPHATEC SPINE, INC OSSEOSCREW OSSEOSCREW F TI HIGH TOP 6.5 X 50MM Back to Search Results
Model Number 53165-50; 53165-50
Device Problems Output Problem (3005); Physical Resistance/Sticking (4012)
Patient Problem Insufficient Information (4580)
Event Date 06/24/2021
Event Type  Injury  
Manufacturer Narrative
The returned device is currently being evaluated. A follow up report with results of the investigation will be submitted upon completion.
 
Event Description
After removing a screw, the surgeon was unable to decompress the expansion area because the tulip was locked in place.
 
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Brand NameOSSEOSCREW
Type of DeviceOSSEOSCREW F TI HIGH TOP 6.5 X 50MM
Manufacturer (Section D)
ALPHATEC SPINE, INC
1950 camino vida roble
carlsbad CA 92008
Manufacturer Contact
alaba
1950 camino vida roble
carlsbad, CA 92008
7604946771
MDR Report Key12255865
MDR Text Key264479828
Report Number2027467-2021-00053
Device Sequence Number1
Product Code NKB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K181980
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/30/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/30/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Model Number53165-50; 53165-50
Device Lot Number650666; 718434
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/30/2021
Date Manufacturer Received06/30/2021
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: 07/30/2021 Patient Sequence Number: 1
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