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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ALPHATEC SPINE INC TRESTLE LUXE ANTERIOR CERVICAL PLATING SYSTEM; SPINAL INTERVERTEBRAL BODY FIXATION ORTHOSIS
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ALPHATEC SPINE INC TRESTLE LUXE ANTERIOR CERVICAL PLATING SYSTEM; SPINAL INTERVERTEBRAL BODY FIXATION ORTHOSIS Back to Search Results
Model Number 71002-034
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 07/14/2020
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
No evaluation possible.The explanted trestle luxe plate has not been returned.
 
Event or Problem Description
Revision surgery was conducted on (b)(6) 2020 to remove and replace a 2-level trestle luxe plate.The locking mechanism became detached which allowed the screw to protrude.The trestle luxe anterior cervical plating system was initially implanted on (b)(6) 2020.
 
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Brand Name
TRESTLE LUXE ANTERIOR CERVICAL PLATING SYSTEM
Common Device Name
SPINAL INTERVERTEBRAL BODY FIXATION ORTHOSIS
Manufacturer (Section D)
ALPHATEC SPINE INC
5818 el camino real
carlsbad, ca
MDR Report Key10385413
Report Number2027467-2020-00034
Device Sequence Number13922064
Product Code KWQ
UDI-Device Identifier00844856067011
UDI-Public(01)00844856067011
Combination Product (Y/N)N
Initial Reporter CountryUS
PMA/510(K) Number
K102820
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2020
Device Explanted Year2020
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 07/13/2020
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? No
Operator of Device Health Professional
Device Model Number71002-034
Device Catalogue Number71002-034
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 07/13/2020
Initial Report FDA Received Date08/10/2020
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 Age73 YR
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