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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WARSAW ORTHOPEDIC, INC. VERTEX RECONSTRUCTION SYSTEM; APPLIANCE, FIXATION, SPINAL INTERLAMINAL
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WARSAW ORTHOPEDIC, INC. VERTEX RECONSTRUCTION SYSTEM; APPLIANCE, FIXATION, SPINAL INTERLAMINAL Back to Search Results
Catalog Number 7750445
Device Problem Disconnection (1171)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/08/2014
Event Type  malfunction  
Event Description
It was reported that the patient underwent a posterior spinal surgical procedure.It was reported that the rod connector set screw would not tighten enough to hold the rod from slipping.The surgeon loosened the set screw and it completely disengaged.The domino was removed and replaced.No patient complications were reported.
 
Manufacturer Narrative
(b)(4).Neither the device nor applicable imaging films were returned to the manufacturer for evaluation, therefore, the cause of the event cannot be determined.
 
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Brand Name
VERTEX RECONSTRUCTION SYSTEM
Type of Device
APPLIANCE, FIXATION, SPINAL INTERLAMINAL
Manufacturer (Section D)
WARSAW ORTHOPEDIC, INC.
2500 silveus crossing
warsaw IN 46582
Manufacturer (Section G)
MEDTRONIC SOFAMOR DANEK
1800 pyramid place
memphis TN 38132
Manufacturer Contact
huzefa mamoola
1800 pyramid place
memphis, TN 38132
9013963133
MDR Report Key3863751
MDR Text Key4595750
Report Number1030489-2014-02721
Device Sequence Number1
Product Code KWP
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K090714
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial
Report Date 05/13/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/10/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number7750445
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received05/13/2014
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
ROD
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