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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
Model Number 108-ET-6540C
Device Problems Fracture (1260); Mechanical Problem (1384)
Patient Problem Failure of Implant (1924)
Event Date 10/21/2021
Event Type  Injury  
Manufacturer Narrative
Though revision surgery occurred, pathology department would not release device, and the devices were not returned.Device is not available for evaluation.Additionally, no event radiographs of the device were provided for analysis.Photo of the fractured screw confirmed the event.Unknown factors include: patient activity at the time or prior to the event, patient bone quality, the degree of spinal instability, the longevity the degree of post lateral pseudarthrosis, patient compliance with post-operative care instructions or if the patient sustained a fall/impact of any sort (no trauma was reported.).Root cause or specific failure mode cannot be determined.
 
Event Description
As part of a retrospective review presentation spanning 2019-2021 given by an orthopedic medical group, it was noted that a patient received a plf with bilateral posterior fixation from l5- s1 on (b)(6) 2020.One year post operatively reported the s1 bone screw(s) had fractured.Revision surgery was performed on (b)(6) 2021.
 
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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 Key12801211
MDR Text Key282967648
Report Number3004893332-2021-00021
Device Sequence Number1
Product Code NKB
UDI-Device Identifier00840916131852
UDI-Public(01)00840916131852(10)192926(11)200613
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 11/11/2021
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
Device Operator Health Professional
Device Model Number108-ET-6540C
Device Catalogue Number108-ET-6540C
Device Lot Number192926
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 10/14/2021
Initial Date FDA Received11/11/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/13/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age34 YR
Patient SexMale
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