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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 Problems Detachment Of Device Component (1104); Device Dislodged or Dislocated (2923)
Patient Problem Failure of Implant (1924)
Event Date 05/21/2018
Event Type  Injury  
Manufacturer Narrative
No evaluation possible. The explanted set screws have been discarded by the user facility.
 
Event Description
Patient bent over and felt a pop. Patient followed up with surgeon and confirmed with x-rays that the set screws located at the s2 had become detached. The surgeon was able to retrieve them with ease during the revision in (b)(6) 2018. The case consisted of removing and replacing both set screws at the s2. The arsenal fixation system was originally implanted (b)(6) 2018 at the l2 thru pelvis.
 
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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 Key7619677
MDR Text Key111681959
Report Number2027467-2018-00038
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 05/31/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/20/2018
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 Received05/31/2018
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: 06/20/2018 Patient Sequence Number: 1
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