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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SPINAL ELEMENTS, INC AMENDIA CERVICAL PLATE SYSTEM; ANTERIOR CERVICAL PLATE
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SPINAL ELEMENTS, INC AMENDIA CERVICAL PLATE SYSTEM; ANTERIOR CERVICAL PLATE Back to Search Results
Device Problems Failure to Osseointegrate (1863); Migration (4003)
Patient Problem Local Reaction (2035)
Event Date 10/16/2019
Event Type  Injury  
Manufacturer Narrative
It cannot be determined/confirmed that devices were manufactured by spinal elements.Allegedly the patient received an acp anterior cervical plate, but no product information, data, or evidence was received, confirming the manufacturer of the subject device.Allegation of allergic reaction, could not be confirmed.Patient reported she may have a screw backing out, but no images, radiographs, or medical evidence has been provided.Complaint can not be confirmed.
 
Event Description
Patient called inquiring about the material composition of the cervical implant she has.She believes she might be having an allergic reaction as a result of the implants.She also thinks she might has a screw backing out.
 
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Brand Name
AMENDIA CERVICAL PLATE SYSTEM
Type of Device
ANTERIOR CERVICAL PLATE
Manufacturer (Section D)
SPINAL ELEMENTS, INC
3115 melrose drive, suite 200
carlsbad CA 92010
Manufacturer Contact
peter perhach
3115 melrose drive, suite 200
carlsbad, CA 92010
7606071830
MDR Report Key9280740
MDR Text Key165216485
Report Number3004893332-2019-00010
Device Sequence Number1
Product Code KWQ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K152455
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Reporter Occupation Other
Type of Report Initial
Report Date 10/16/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/05/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator No Information
Was Device Available for Evaluation? No
Date Manufacturer Received10/16/2019
Was Device Evaluated by Manufacturer? No
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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