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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ALPHATEC SPINE, INC. CURVED THORACIC PROBE, BALL HANDLE (STAINLESS STEEL); HXB
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ALPHATEC SPINE, INC. CURVED THORACIC PROBE, BALL HANDLE (STAINLESS STEEL); HXB Back to Search Results
Model Number 87046-05
Device Problem Break (1069)
Patient Problem No Information (3190)
Event Date 05/11/2018
Event Type  malfunction  
Manufacturer Narrative
No evaluation possible at this time.The instrument has not been returned for evaluation.Upon the receipt of additional information and/or the product in question, a follow-up report will be submitted.
 
Event Description
During use, the arsenal probe broke/snapped at the top of the gold etched line.
 
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Brand Name
CURVED THORACIC PROBE, BALL HANDLE (STAINLESS STEEL)
Type of Device
HXB
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 Key7560914
MDR Text Key110072144
Report Number2027467-2018-00034
Device Sequence Number1
Product Code HXB
UDI-Device Identifier00844856074057
UDI-Public(01)00844856074057
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation Other
Type of Report Initial
Report Date 05/11/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/01/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Physician
Device Model Number87046-05
Device Catalogue Number87046-05
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Date Manufacturer Received05/11/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age32 YR
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