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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ALPHATEC SPINE, INC. BATTALION; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR
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ALPHATEC SPINE, INC. BATTALION; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR Back to Search Results
Model Number 27012-269-S
Health Effect - Clinical Code Insufficient Information (4580)
Date of Event 06/02/2021
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
The device has not returned as it remains in-situ.If any additional information is provided, a supplemental report will be submitted.
 
Event or Problem Description
A report was received on (b)(6) 2021 indicating an expired cage was implanted into a patient.No revision surgery scheduled at this time.
 
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Brand Name
BATTALION
Common Device Name
INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR
Manufacturer (Section D)
ALPHATEC SPINE, INC.
1950 camino vida roble
carlsbad CA 92008
MDR Report Key12108290
Report Number2027467-2021-00049
Device Sequence Number14559107
Product Code MAX
UDI-Device Identifier00840967107615
UDI-Public00840967107615
Combination Product (Y/N)N
Initial Reporter StateCA
Initial Reporter CountryUS
PMA/510(K) Number
K143740
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) 06/02/2021
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? No
Operator of Device No Information
Device Model Number27012-269-S
Device Catalogue Number27012-269-S
Device Lot Number701154R1
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 06/02/2021
Initial Report FDA Received Date07/02/2021
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;
Patient Age43 YR
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