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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
Model Number 11-2644
Health Effect - Clinical Code Insufficient Information (4580)
Date of Event 09/07/2021
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
The reported condition was confirmed via radiographic image.The removed implant was returned without the delivery device.Visual inspection of the returned implant found no abnormalities.Based on the evaluation findings, we could not determine the exact cause of the difficulty reported.
 
Event or Problem Description
At approximately three months post-operatively, the surgeon performed a surgical procedure to remove an implant that had migrated.
 
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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 Key12586458
Report Number3004638600-2021-00007
Device Sequence Number19910149
Product Code MAX
UDI-Device Identifier10840642106909
UDI-Public10840642106909
Combination Product (Y/N)N
Initial Reporter StateMI
Initial Reporter CountryUS
PMA/510(K) Number
K152620
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2021
Device Explanted Year2021
Serviced by Third Party (Y/N)N
Reporter Type Manufacturer
Report Source distributor,health profession
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 09/07/2021
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? No
Operator of Device Health Professional
Device Model Number11-2644
Device Catalogue Number11-2644
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/15/2021
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 09/07/2021
Initial Report FDA Received Date10/06/2021
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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