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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SPINE WAVE, INC. PROFICIENT POSTERIOR CERVICAL SPINE SYSTEM; POSTERIOR CERVICO-THORACIC FIXATION SYSTEM
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SPINE WAVE, INC. PROFICIENT POSTERIOR CERVICAL SPINE SYSTEM; POSTERIOR CERVICO-THORACIC FIXATION SYSTEM Back to Search Results
Model Number 11-8999
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 01/17/2020
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
The condition reported was confirmed on radiographic imaging.Deformation was observed which is consistent with the reported event.There is insufficient evidence to establish an exact root cause.
 
Event or Problem Description
Approximately 4 weeks post-operatively, the surgeon noted on radiographic imaging that the locking screws did not appear tight.A surgical procedure was performed to replace the locking screws and extend the construct.
 
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Brand Name
PROFICIENT POSTERIOR CERVICAL SPINE SYSTEM
Common Device Name
POSTERIOR CERVICO-THORACIC FIXATION SYSTEM
Manufacturer (Section D)
SPINE WAVE, INC.
3 enterprise drive
suite 210
shelton, ct
MDR Report Key9729765
Report Number3004638600-2020-00001
Device Sequence Number362079
Product Code NKG
UDI-Device Identifier10840642111217
UDI-Public10840642111217
Combination Product (Y/N)N
Initial Reporter CountryUS
PMA/510(K) Number
K162639
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2019
Device Explanted Year2020
Reporter Type Manufacturer
Report Source distributor,health profession
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 01/22/2020
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 Number11-8999
Device Catalogue Number11-8999
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/22/2020
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 01/22/2020
Initial Report FDA Received Date02/19/2020
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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