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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 09/17/2021
Event Type  malfunction  
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 l4- s1 on (b)(6) 2021.Two months post operatively ((b)(6) 2021) radiographs depicted the left s1 bone screw had fractured.Plan for revision surgery is unknown.
 
Manufacturer Narrative
Radiograph images confirmed the complaint.A plan for revision is unknown.Device is not available 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.Unknown factors include: patient activity at the time or prior to the event, patient bone quality, the degree of spinal instability, 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.
 
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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 Key12801086
MDR Text Key282227334
Report Number3004893332-2021-00019
Device Sequence Number1
Product Code NKB
UDI-Device Identifier00840916131852
UDI-Public00840916131852
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? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number108-ET-6540C
Device Catalogue Number108-ET-6540C
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
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 Age44 YR
Patient SexFemale
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