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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SPINE WAVE, INC. SNIPER SPINE SYSTEM; INSTRUMENT
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SPINE WAVE, INC. SNIPER SPINE SYSTEM; INSTRUMENT Back to Search Results
Catalog Number 10-4100.2
Device Problem Material Fragmentation (1261)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 11/28/2017
Event Type  Injury  
Event Description
A broken fragment of the device was identified during routine radiographic patient follow up.Although the patient was asymptomatic, the surgeon elected to perform a surgical procedure to retrieve the fragment.No complications from either surgical procedure have been reported.
 
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Brand Name
SNIPER SPINE SYSTEM
Type of Device
INSTRUMENT
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 Key7149430
MDR Text Key95897727
Report Number3004638600-2017-00010
Device Sequence Number1
Product Code MNH
UDI-Device Identifier10840642108118
UDI-Public10840642108118
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K100605
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,health profession
Reporter Occupation Physician
Type of Report Initial
Report Date 11/28/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/27/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Physician
Device Catalogue Number10-4100.2
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/28/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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