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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SPINE WAVE, INC. CAPSURE SPINAL SYSTEM; PEDICAL SCREW SYSTEM
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SPINE WAVE, INC. CAPSURE SPINAL SYSTEM; PEDICAL SCREW SYSTEM Back to Search Results
Catalog Number 11-3752
Health Effect - Clinical Code Nonunion/Delayed-union Bone Fracture (2369)
Date of Event 05/28/2019
Type of Reportable Event Malfunction
Event or Problem Description
Approximately twenty months after the initial surgery during a planned revision of the existing pedicle screw construct due to a reported non-union, a broken screw was identified at the l5 vertebral level.
 
Additional Manufacturer Narrative
The subject pedicle screw was received for evaluation.Inspection of the device confirmed damage in a manner consistent with the reported event.A review of the device history record found no non-conformances.Based on the results of our evaluation, an exact root cause cannot be determined.
 
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Brand Name
CAPSURE SPINAL SYSTEM
Common Device Name
PEDICAL SCREW SYSTEM
Manufacturer (Section D)
SPINE WAVE, INC.
3 enterprise drive
suite 210
shelton CT 06484
MDR Report Key8737378
Report Number3004638600-2019-00009
Device Sequence Number11148316
Product Code NKB
UDI-Device Identifier10840642105186
UDI-Public10840642105186
Combination Product (Y/N)N
Initial Reporter StateLA
Initial Reporter CountryUS
PMA/510(K) Number
K172175
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2017
Device Explanted Year2019
Reporter Type Manufacturer
Report Source company representative,distri
Initial Reporter Occupation Physician
Type of Report Initial,Followup
Report Date (Section B) 05/30/2019
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
Operator of Device Health Professional
Device Catalogue Number11-3752
Device Lot Number663M09
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/05/2019
Initial Date Received by Manufacturer 05/30/2019
Supplement Date Received by Manufacturer05/30/2019
Initial Report FDA Received Date06/26/2019
Supplement Report FDA Received Date07/26/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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