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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY SPINE INC EXPEDIUM SPINE SYSTEM PRE-BENT SPINAL ROD 5.5 X 75MM ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

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DEPUY SPINE INC EXPEDIUM SPINE SYSTEM PRE-BENT SPINAL ROD 5.5 X 75MM ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE Back to Search Results
Catalog Number 179772075
Device Problem Unintended Movement (3026)
Patient Problem No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative
The device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report. (b)(4). 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 australia as follows: it was reported that on an unknown date, the set screw from the right l4 screw ¿popped-off¿ during an unknown procedure. Revision surgery was required. The surgeon removed the remaining two set screws at l5/s1, rod, and l4 screw. No further information was provided. Concomitant device reported: unknown screws (part# unknown, lot# unknown, quantity unknown ). Unknown rods (part# unknown, lot# unknown, quantity unknown ). This report is for one (1) expedium spine system pre-bent spinal rod 5. 5 x 75mm. This is report 3 of 5 for (b)(4).
 
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Brand NameEXPEDIUM SPINE SYSTEM PRE-BENT SPINAL ROD 5.5 X 75MM
Type of DeviceORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE
Manufacturer (Section D)
DEPUY SPINE INC
325 paramount drive
raynham MA 02767
Manufacturer Contact
kara ditty-bovard
325 paramount drive
raynham, MA 02767
6103142063
MDR Report Key10869194
MDR Text Key218524537
Report Number1526439-2020-02244
Device Sequence Number1
Product Code NKB
UDI-Device Identifier10705034077963
UDI-Public(01)10705034077963
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
K131802
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 12/14/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/19/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number179772075
Device Lot NumberTBDFT7TR
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/16/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/29/2020
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 11/19/2020 Patient Sequence Number: 1
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