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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: 1800 PYRAMID PLACE
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1800 PYRAMID PLACE Back to Search Results
Device Problem Material Deformation (2976)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/21/2016
Event Type  malfunction  
Manufacturer Narrative
Neither the device nor films of applicable imaging studies were returned to the manufacturer for evaluation.Therefore, we are unable to determine the definitive cause of the reported event.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was reported that on(b)(6) 2016, patient presented with pre-operative diagnosis: cervical spondylosis.For which patient underwent posterior fusion at levels c2-t2.Intra-op, during final tightening, set screw stripped.The set screw was left in the patient¿s body.No patient complications were reported.
 
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Manufacturer (Section D)
1800 PYRAMID PLACE
memphis TN 38132
Manufacturer (Section G)
1800 PYRAMID PLACE
memphis TN 38132
Manufacturer Contact
greg anglin
1800 pyramid place
memphis, TN 38132
9013963133
MDR Report Key6253008
MDR Text Key65267848
Report Number1030489-2017-00110
Device Sequence Number1
Product Code KWQ
Combination Product (y/n)N
Reporter Country CodeJA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Physician
Type of Report Initial
Report Date 12/21/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/16/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/21/2016
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
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