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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MSD BARTLETT MFG MANUAL ORTHOPEDIC SURGICAL INSTRUMENT; PROBE
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MSD BARTLETT MFG MANUAL ORTHOPEDIC SURGICAL INSTRUMENT; PROBE Back to Search Results
Catalog Number 803-292
Device Problem Break (1069)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/08/2013
Event Type  malfunction  
Event Description
It was reported that the patient underwent a spinal surgical procedure.It was reported that the tip of the instrument broke off during use.The tip was removed from the patient.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
MANUAL ORTHOPEDIC SURGICAL INSTRUMENT
Type of Device
PROBE
Manufacturer (Section D)
MSD BARTLETT MFG
2975 brother blvd
bartlett TN 38133
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 Key3575036
MDR Text Key18626630
Report Number1030489-2014-00111
Device Sequence Number1
Product Code HXB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
EXEMPT
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 12/16/2013
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/14/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number803-292
Device Lot NumberID08C002
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/16/2013
Was Device Evaluated by Manufacturer? No
Date Device Manufactured04/14/2008
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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