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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
Catalog Number 11-8999
Health Effect - Clinical Code No Code Available (3191)
Date of Event 07/19/2018
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
This event was confirmed through radiographic images.The devices were not returned therefore no evaluation could be performed.
 
Event or Problem Description
At approximately six weeks post-operatively, loose locking screws were noted on routine radiographic follow-up within a multi-level cervico-thoracic construct.A surgical procedure was performed to remove and replace these locking screws and the rods in 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 06484
MDR Report Key7764921
Report Number3004638600-2018-00011
Device Sequence Number120567
Product Code NKG
UDI-Device Identifier10840642111217
UDI-Public10840642111217
Combination Product (Y/N)N
Initial Reporter StateTX
Initial Reporter CountryUS
PMA/510(K) Number
K162639
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2018
Device Explanted Year2018
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 07/19/2018
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 Catalogue Number11-8999
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 07/19/2018
Initial Report FDA Received Date08/08/2018
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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