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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ALPHATEC SPINE, INC INVICTUS SPINAL FIXATION SYSTEM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
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ALPHATEC SPINE, INC INVICTUS SPINAL FIXATION SYSTEM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM Back to Search Results
Model Number 15420-11
Medical Device Problem Code Unintended Movement (3026)
Health Effect - Clinical Code Insufficient Information (4580)
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
The device has not returned.If any additional information is provided, a supplemental report will be submitted.
 
Event or Problem Description
On (b)(6) 2021, a patient underwent a posterior lumbar spinal fusion surgery.Four months postoperatively, it was reported a screw disassociated from the pivoting connector.No patient injury reported.
 
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Brand Name
INVICTUS SPINAL FIXATION SYSTEM
Common Device Name
THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
Manufacturer (Section D)
ALPHATEC SPINE, INC
1950 camino vida roble
carlsbad CA 92008
MDR Report Key12640712
Report Number2027467-2021-00067
Device Sequence Number1296110
Product Code NKB
UDI-Device Identifier00190376283869
UDI-Public(01)00190376283869
Combination Product (Y/N)N
Initial Reporter StateFL
Initial Reporter CountryUS
PMA/510(K) Number
K203056
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2021
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) 09/17/2021
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 No Information
Device Model Number15420-11
Device Catalogue Number15420-11
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 09/17/2021
Initial Report FDA Received Date10/15/2021
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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