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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ALPHATEC SPINE INC ARSENAL SPINAL FIXATION SYSTEM ALPHATEC NAVIGATION SURGICAL INSTRUMENTS

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ALPHATEC SPINE INC ARSENAL SPINAL FIXATION SYSTEM ALPHATEC NAVIGATION SURGICAL INSTRUMENTS Back to Search Results
Model Number 87771
Device Problem Material Split, Cut or Torn (4008)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/18/2020
Event Type  malfunction  
Manufacturer Narrative
The returned instrument is currently being evaluated. A follow up report with results of the investigation will be submitted upon completion.
 
Event Description
The distal tip of an arsenal navigation driver sheared off while attempting to inserter a screw. The detached section was removed but was discarded.
 
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Brand NameARSENAL SPINAL FIXATION SYSTEM
Type of DeviceALPHATEC NAVIGATION SURGICAL INSTRUMENTS
Manufacturer (Section D)
ALPHATEC SPINE INC
5818 el camino real
carlsbad CA 92008
Manufacturer Contact
richard younger
5818 el camino real
carlsbad, CA 92008
7604949286
MDR Report Key10546610
MDR Text Key208178161
Report Number2027467-2020-00041
Device Sequence Number1
Product Code OLO
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K153603
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 08/21/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/17/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number87771
Device Catalogue Number87771
Device Lot Number7825203R1R2
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/15/2020
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/21/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/06/2016
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 09/17/2020 Patient Sequence Number: 1
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