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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
Health Effect - Clinical Code No Code Available (3191)
Date of Event 09/24/2019
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
No evaluation possible at this time.The implant has not been returned nor has the identifying lot number been provided.Upon the receipt of additional information and/or the product in question, a follow-up report will be submitted.
 
Event or Problem Description
Revision surgery was conducted to remove an arsenal set screw located at the l3.Post-op x-rays taken (b)(6) 2019 revealed the set screw had backed out of position.The arsenal spinal fixation system was originally implanted on (b)(6) 2019.
 
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Brand Name
SET SCREW (TI-6AL-4V ELI)
Common Device Name
PEDICLE SCREW SYSTEM
Manufacturer (Section D)
ALPHATEC SPINE INC
5818 el camino real
carlsbad CA 92008
MDR Report Key9224430
Report Number2027467-2019-00050
Device Sequence Number11394132
Product Code NKB
UDI-Device Identifier00840967124582
UDI-Public(01)00840967124582
Combination Product (Y/N)N
Initial Reporter StateNC
Initial Reporter CountryUS
PMA/510(K) Number
K133221
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2019
Device Explanted Year2019
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 09/24/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Operator of Device No Information
Device Model Number47127
Device Catalogue Number47127
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 09/24/2019
Initial Report FDA Received Date10/23/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Hospitalization;
Patient Age58 YR
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