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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ALPHATEC SPINE, INC. INSIGNIA; APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

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ALPHATEC SPINE, INC. INSIGNIA; APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY Back to Search Results
Model Number 336-0364
Device Problems Fracture (1260); Device Dislodged or Dislocated (2923)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/06/2023
Event Type  malfunction  
Manufacturer Narrative
The implants remain in-situ.There are no plans for revision surgery.The identifying lot number was not provided; therefore, a review of the device history record could not be conducted.Based on the information provided, a root cause could not be determined.If additional information is received, a supplemental report will be filed accordingly.Labeling review: "warnings/cautions/precautions: potential risks identified with the use of this device, which may require additional surgery, include device component fracture, loss of fixation, non-union, fracture of the vertebrae, and necrosis of bone, neurological injury and vascular or visceral injury." possible adverse effects: the following complications and adverse reactions have been shown to occur with the use of similar spinal instrumentation.These effects and any other known by the surgeon should be discussed with the patient preoperatively.1.Loss of desired spinal curvature, spinal correction and/or a gain or loss in height.2.Initial or delayed loosening, disassembly, bending, dislocation and/or breakage of device components.".
 
Event Description
On (b)(6) 2023, a patient underwent a 3-level anterior cervical discectomy and fusion spinal procedure.During a postoperative visit, a radiograph image revealed an inferior screw backing out of the plate and a superior screw shank fracture.
 
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Brand Name
INSIGNIA
Type of Device
APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
Manufacturer (Section D)
ALPHATEC SPINE, INC.
1950 camino vida roble
carlsbad CA 92008
Manufacturer (Section G)
ALPHATEC SPINE, INC.
1950 camino vida roble
carlsbad CA 92008
Manufacturer Contact
wesley channell
1950 camino vida roble
carlsbad, CA 92008
9014283693
MDR Report Key18070166
MDR Text Key327381879
Report Number2027467-2023-00073
Device Sequence Number1
Product Code KWQ
UDI-Device Identifier00190376423685
UDI-Public(01)00190376423685
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K213443
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 11/03/2023
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? No
Device Operator Health Professional
Device Model Number336-0364
Device Catalogue Number336-0364
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 10/06/2023
Initial Date FDA Received11/03/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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