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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ALPHATEC SPINE, INC. ARSENAL SPINAL FIXATION SYSTEM; PEDICLE SCREW SYSTEM
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ALPHATEC SPINE, INC. ARSENAL SPINAL FIXATION SYSTEM; PEDICLE SCREW SYSTEM Back to Search Results
Model Number 47127
Health Effect - Clinical Code Insufficient Information (4580)
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
No evaluation possible at this time.The implant has not been removed from the patient nor has the identifying lot number been provided.Upon the receipt of additional information and/or the product in question, a follow-up report will be submitted.
 
Event or Problem Description
Post op x-rays revealed the set screw positioned at the l5 had become disengaged from the polyaxial screw.At this time the patient is doing well therefore the surgeon is not planning on revising.
 
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Brand Name
ARSENAL SPINAL FIXATION SYSTEM
Common Device Name
PEDICLE SCREW SYSTEM
Manufacturer (Section D)
ALPHATEC SPINE, INC.
1950 camino vida roble
carlsbad CA 92008
MDR Report Key11576410
Report Number2027467-2021-00013
Device Sequence Number16933907
Product Code NKB
UDI-Device Identifier00840967124582
UDI-Public(01)00840967124582
Combination Product (Y/N)N
Initial Reporter CountryUS
PMA/510(K) Number
K133221
Number of Events Summarized1
Summary Report (Y/N)N
Serviced by Third Party (Y/N)N
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 02/25/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Model Number47127
Device Catalogue Number47127
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 02/25/2021
Initial Report FDA Received Date03/26/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Other;
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