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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ALPHATEC SPINE INC ILLICO MIS POSTERIOR FIXATION SYSTEM PEDICKE SCREW SYSTEM

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ALPHATEC SPINE INC ILLICO MIS POSTERIOR FIXATION SYSTEM PEDICKE SCREW SYSTEM Back to Search Results
Model Number 73865-40
Device Problems Difficult to Remove (1528); Material Integrity Problem (2978)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/18/2020
Event Type  Injury  
Manufacturer Narrative
The returned implants are currently under investigation. A follow up report with results of the investigation will be submitted upon completion.
 
Event Description
Revision surgery was conducted (b)(6) 2020 to extend the fixation from l4/5 to l3-l5 due to adjacent segment disease. While the surgeon tried to remove the implants, the id of the polyaxial screw was stripped/crushed and could not be removed. Eventually, after a 2 hour delay and alternative instrumentation, the surgeon was able to remove the implants. The illico mis posterior fixation system was originally implanted on (b)(6) 2015 at the l4/5.
 
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Brand NameILLICO MIS POSTERIOR FIXATION SYSTEM
Type of DevicePEDICKE SCREW SYSTEM
Manufacturer (Section D)
ALPHATEC SPINE INC
5818 el camino real
carlsbad, ca
Manufacturer Contact
richard younger
5818 el camino real
carlsbad, ca 
4949286
MDR Report Key9910071
MDR Text Key191676710
Report Number2027467-2020-00022
Device Sequence Number1
Product Code NKB
UDI-Device Identifier00844856043190
UDI-Public(01)00844856043190(10)683043
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K123623
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 03/04/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/01/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number73865-40
Device Catalogue Number73865-40
Device Lot Number683043
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/16/2020
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/04/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/25/2014
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 04/01/2020 Patient Sequence Number: 1
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