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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SPINE WAVE, INC. VELOCITY EXPANDABLE INTERBODY DEVICE; INTERVERTEBRAL BODY FUSION DEVICE
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SPINE WAVE, INC. VELOCITY EXPANDABLE INTERBODY DEVICE; INTERVERTEBRAL BODY FUSION DEVICE Back to Search Results
Catalog Number 11-2645
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 12/20/2018
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
The device was not returned for evaluation.Review of the production records found no non-conformances to specification.
 
Event or Problem Description
At an unspecified time post-operatively, the surgeon noted that the implant construct had migrated.A surgical procedure was performed to remove and replace the device.
 
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Brand Name
VELOCITY EXPANDABLE INTERBODY DEVICE
Common Device Name
INTERVERTEBRAL BODY FUSION DEVICE
Manufacturer (Section D)
SPINE WAVE, INC.
3 enterprise drive
suite 210
shelton CT 06484
MDR Report Key8259112
Report Number3004638600-2019-00001
Device Sequence Number158613
Product Code MAX
UDI-Device Identifier10840642106916
UDI-Public10840642106916
Combination Product (Y/N)N
Initial Reporter StateVA
Initial Reporter CountryUS
PMA/510(K) Number
K152620
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2018
Device Explanted Year2018
Reporter Type Manufacturer
Report Source distributor,health profession
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 01/14/2019
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? No
Operator of Device Health Professional
Device Expiration Date03/06/2020
Device Catalogue Number11-2645
Device Lot Number741T20
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 01/14/2019
Initial Report FDA Received Date01/17/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
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