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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SPINAL ELEMENTS, INC OVERWATCH; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
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SPINAL ELEMENTS, INC OVERWATCH; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM Back to Search Results
Device Problems Fracture (1260); Mechanical Problem (1384)
Patient Problem Failure of Implant (1924)
Event Date 11/02/2021
Event Type  Injury  
Manufacturer Narrative
Allegedly revision has occurred.Device is not released for evaluation.Part number and lot number were not provided.Dhr review cannot be completed at this time.To date, multiple communication attempts have been made to retrieve the product information and lot number and event information.
 
Event Description
As part of a retrospective review presentation spanning 2019-2021 given by an orthopedic medical group, it was reported that a patient was revised (b)(6) 2021.Allegedly the revision was required as a result of a fractured screw.It is unknown if this was a patient event already reported and awaiting revision or if this revision was a new event.No event information was provided.
 
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Brand Name
OVERWATCH
Type of Device
THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
Manufacturer (Section D)
SPINAL ELEMENTS, INC
3115 melrose drive, suite 200
carlsbad CA 92010
Manufacturer Contact
peter perhach
3115 melrose drive, suite 200
carlsbad, CA 92010
7606071830
MDR Report Key12902677
MDR Text Key281579495
Report Number3004893332-2021-00023
Device Sequence Number1
Product Code NKB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K161842
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Distributor
Reporter Occupation Physician
Type of Report Initial
Report Date 11/30/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/30/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/02/2021
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 Sequence Number1
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