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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY SPINE INC UNIVERSAL NAVIGATION EXPEDIUM SPINE SYSTEM THORACIC PROBE, STRAIGH ORTHOPAEDIC STEREOTAXIC INSTRUMENT

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DEPUY SPINE INC UNIVERSAL NAVIGATION EXPEDIUM SPINE SYSTEM THORACIC PROBE, STRAIGH ORTHOPAEDIC STEREOTAXIC INSTRUMENT Back to Search Results
Model Number 279702030N
Device Problems Break (1069); Entrapment of Device (1212)
Patient Problems Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/03/2021
Event Type  malfunction  
Manufacturer Narrative
Complainant part is not expected to be returned for manufacturer review/investigation. Without a lot number the device history records review could not be completed. Product was not returned. Based on the information available, it has been determined that no corrective and/or preventative action is proposed. This complaint will be accounted for and monitored via post market surveillance activities. If additional information is made available, the investigation will be updated as applicable. Device was used for treatment, not diagnosis. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
Event Description
Device report from synthes reports an event in (b)(6) as follows it was reported that on (b)(6) 2021, a probe broke off 4cm down the shaft and the tip was lodged in the sacrum of the patient and had to use a drill to extract the fragment. Procedure was completed successfully with thirty(30) minutes of surgical delay. This report is for one (1) universal navigation expedium spine system thoracic probe, straight. This is report 1 of 1 for complaint (b)(4).
 
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Brand NameUNIVERSAL NAVIGATION EXPEDIUM SPINE SYSTEM THORACIC PROBE, STRAIGH
Type of DeviceORTHOPAEDIC STEREOTAXIC INSTRUMENT
Manufacturer (Section D)
DEPUY SPINE INC
325 paramount drive
raynham MA 02767
Manufacturer Contact
kara ditty-bovard
1302 wright lane east
west chester, PA 19380
6107195000
MDR Report Key12584836
MDR Text Key275003982
Report Number1526439-2021-02117
Device Sequence Number1
Product Code OLO
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
K140927
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup
Report Date 09/09/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/06/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number279702030N
Device Catalogue Number279702030N
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 Received10/11/2021
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 Unkown

Patient Treatment Data
Date Received: 10/06/2021 Patient Sequence Number: 1
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