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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SPINE WAVE, INC. SALVO SPINE SYSTEM PEDICLE SCREW SYSTEM

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SPINE WAVE, INC. SALVO SPINE SYSTEM PEDICLE SCREW SYSTEM Back to Search Results
Model Number 11-6530
Device Problem Material Separation (1562)
Patient Problem Insufficient Information (4580)
Event Date 10/28/2020
Event Type  malfunction  
Event Description
During routine post-operative follow up, four weeks post-operatively, the surgeon identified a separated screw in the pedicle screw construct via radiograph. The pedicle screw and construct were left in place as the surgeon reported the patient is asymptomatic.
 
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Brand NameSALVO SPINE SYSTEM
Type of DevicePEDICLE SCREW SYSTEM
Manufacturer (Section D)
SPINE WAVE, INC.
3 enterprise drive
suite 210
shelton CT 06484
Manufacturer (Section G)
SPINE WAVE, INC.
3 enterprise drive
suite 210
shelton CT 06484
Manufacturer Contact
ronald smith
3 enterprise drive
suite 210
shelton, CT 06484
2039449494
MDR Report Key10906766
MDR Text Key239584588
Report Number3004638600-2020-00005
Device Sequence Number1
Product Code NKB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K182954
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial
Report Date 10/28/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/25/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number11-6530
Device Catalogue Number11-6530
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/28/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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