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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 No Known Impact Or Consequence To Patient (2692)
Date of Event 06/10/2020
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
No evaluation possible at this time.The international user facility has not returned the explanted set screws to (b)(4).Upon receipt of the device and/or additional information a follow up report will be submitted.
 
Event or Problem Description
Revision surgery was conducted on (b)(6) 2020 to remove & replace two arsenal set screws.Post-op images taken (b)(6) 2020 revealed both set screws located at the l3 had backed out of position.The arsenal spinal fixation system was implanted on (b)(6) 2020 at the t11-l3.
 
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Brand Name
ARSENAL SPINAL FIXATION SYSTEM
Common Device Name
PEDICLE SCREW SYSTEM
Manufacturer (Section D)
ALPHATEC SPINE INC
5818 el camino real
carlsbad, ca
MDR Report Key10283253
Report Number2027467-2020-00031
Device Sequence Number13574537
Product Code NKB
UDI-Device Identifier00840967124582
UDI-Public(01)00840967124582(10)8460801
Combination Product (Y/N)N
Initial Reporter CountryJA
PMA/510(K) Number
K133221
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2020
Device Explanted Year2020
Reporter Type Manufacturer
Report Source foreign
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 06/18/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Model Number47127
Device Catalogue Number47127
Device Lot Number8460801
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 06/18/2020
Initial Report FDA Received Date07/16/2020
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 Hospitalization;
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