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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ALPHATEC SPINE INC OCCIPITAL PLATE ASSEMBLY, 56 MM (TI-6AI-4V ELI, CP TITANIUM - GRADE II) ROD AND SCREW SPINAL INSTRUMENTATION

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ALPHATEC SPINE INC OCCIPITAL PLATE ASSEMBLY, 56 MM (TI-6AI-4V ELI, CP TITANIUM - GRADE II) ROD AND SCREW SPINAL INSTRUMENTATION Back to Search Results
Model Number 75000-056
Device Problem Fitting Problem (2183)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/02/2018
Event Type  malfunction  
Manufacturer Narrative
A review of the device history records revealed no manufacturing or processing related irregularities. The avalon occipital plate was found to be properly manufactured and released in accordance with design specifications. No evaluation possible at this time. The international customer has not returned the explanted construct. Upon the receipt of additional information and/or the product in question, a follow-up report will be submitted.
 
Event Description
After setting the rod on bushing of occipital bone plate, the doctor installed avalon set screws. Both of the bushings were widened by the installation and set screws could not be tightened.
 
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Brand NameOCCIPITAL PLATE ASSEMBLY, 56 MM (TI-6AI-4V ELI, CP TITANIUM - GRADE II)
Type of DeviceROD AND SCREW SPINAL INSTRUMENTATION
Manufacturer (Section D)
ALPHATEC SPINE INC
5818 el camino real
carlsbad CA 92008
Manufacturer Contact
richard younger
5818 el camino real
carlsbad, CA 92008
7604946842
MDR Report Key8331516
MDR Text Key137866137
Report Number2027467-2019-00005
Device Sequence Number1
Product Code NKB
UDI-Device Identifier00844856068728
UDI-Public(01)00844856068728(10)8047401
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K111076
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 01/17/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/12/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number75000-056
Device Catalogue Number75000-056
Device Lot Number8047401
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/11/2019
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/17/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/06/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

Patient Treatment Data
Date Received: 02/12/2019 Patient Sequence Number: 1
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