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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ALPHATEC SPINE, INC. SET SCREW (TI-6AL-4V ELI) PEDICLE SCREW SYSTEM

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ALPHATEC SPINE, INC. SET SCREW (TI-6AL-4V ELI) PEDICLE SCREW SYSTEM Back to Search Results
Model Number 47127
Device Problem Detachment Of Device Component (1104)
Patient Problem Failure of Implant (1924)
Event Date 04/27/2018
Event Type  Injury  
Manufacturer Narrative
No evaluation possible at this time. The user facility has not released the implants. Upon the receipt of additional information and/or the return of the implants a follow-up report will be submitted.
 
Event Description
Three (3) weeks post-op x-rays revealed the rods at the distal end of a long construct in a patient with marfan syndrome, had slip from heads of the pedicle screws. During the revision ((b)(6) 2018), both the right and left l4 set screws were found to be loose. Both loose set screws remained attached within the heads of the polyaxial screws. The arsenal spinal fixation system was originally implanted on (b)(6) 2018 at the t2 thru l4 to correct a 50-60° curve.
 
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Brand NameSET SCREW (TI-6AL-4V ELI)
Type of DevicePEDICLE SCREW SYSTEM
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 Key7522634
MDR Text Key108547973
Report Number2027467-2018-00026
Device Sequence Number1
Product Code NKB
UDI-Device Identifier00840967124582
UDI-Public(01)00840967124582
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K133221
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation
Type of Report Initial
Report Date 04/17/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/17/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number47127
Device Catalogue Number47127
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received04/17/2018
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 Treatment Data
Date Received: 05/17/2018 Patient Sequence Number: 1
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