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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 No Information (3190)
Event Date 04/25/2018
Event Type  Injury  
Manufacturer Narrative
The explanted arsenal set screws are currently being evaluated. A follow up report with results of the investigation will be submitted upon completion.
 
Event Description
During a post-op visit, radiograph showed the set screws had come off the t10 and t11. Revision surgery was conducted (b)(6) 2018. Both the t10 and t11 set screws and pedicle screws were removed and replaced. Additional screws placed at t12 and l1. The original rod was cut between l1 and l2 and a rod connector was used to connect from t10 to the l2 screw the arsenal spinal fixation system was originally implanted (b)(6) 2017 from the t10 thru s1.
 
Manufacturer Narrative
The set screw bottom surface is the surface that interacts with the rod to create a stable construct, therefore the wear pattern on these surface were inspected. The expected contact surface between set screw and rod after fully tightened results in two inline marks on the set screw. The explant set screws displayed a "starburst" wear pattern on the bottom surface of the set screw which is indicative of motion between rod and screw. One of the set screws displayed a more "random" wear pattern, but some of the "starburst" pattern as well indicating motion. The set screws had no significant wear or shear/deformation of the threads. No significant wear or deformation was visible on the screw bodies. Therefore, the set screw disengagement may be attributed to a non-normalized rod which caused repeated motion at the rod-screw interface resulting in set screw back out.
 
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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 Key7540229
MDR Text Key109122579
Report Number2027467-2018-00030
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,Followup
Report Date 04/30/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/24/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number47127
Device Catalogue Number47127
Device Lot Number7987002
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/03/2018
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received04/30/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/12/2017
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: 05/24/2018 Patient Sequence Number: 1
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