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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-SS
Device Problems Mechanical Problem (1384); Detachment of Device or Device Component (2907)
Patient Problem Failure of Implant (1924)
Event Date 12/13/2021
Event Type  Injury  
Event Description
Patient underwent plif spinal fusion surgery (l5-s1) on (b)(6) 2021 to correct grade 3 spondylolisthesis and pain.Two weeks post operatively it was discovered that the left l5 lock screw had loosened.Revision surgery to replace the screw with a larger screw occurred on (b)(6) 2022.
 
Manufacturer Narrative
Radiographs received confirmed the event.Returned devices were dimensionally measured and found to be in specification.Torque handle was tested and was in specification.Subject device was visually evaluated and marring of the bottom of the set screw that was in contact with the rod, suggests loosening and instability.Final tightening of the lock screw cannot be confirmed from the markings on the bottom of the set screw.Unknown factors include: patient activity at the time or prior to the event, patient bone quality, the degree of spinal instability or patient compliance with post-operative care instructions or if the patient sustained a fall/impact of any sort (no trauma was reported).Root cause is unknown.
 
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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 Key13549446
MDR Text Key285754842
Report Number3004893332-2022-00003
Device Sequence Number1
Product Code NKB
UDI-Device Identifier00840916131234
UDI-Public(01)00840916131234(10)201765(11)210526
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 02/17/2022
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-SS
Device Catalogue Number108-SS
Device Lot Number201765
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/19/2022
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 01/19/2022
Initial Date FDA Received02/17/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/26/2021
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 Weight84 KG
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