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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY SPINE INC UNKNOWN AWLS EXPEDIUM® VERSE SPINE SYSTEM

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DEPUY SPINE INC UNKNOWN AWLS EXPEDIUM® VERSE SPINE SYSTEM Back to Search Results
Catalog Number UNK AWLS
Device Problem Device Damaged Prior to Use (2284)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
Product complaint #: (b)(4). 510k: this report is for an unknown awe/unknown lot number. Without the specific part number, the udi number and 510k number is unknown. 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 as no product was received. The investigation could not be completed; no conclusion could be drawn at the time of filing this report. Investigation summary product was not returned. Based on the information available, it has been determined that no corrective and 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 dr (b)(6) was performing a l4-5 right sided navigated posterior instrumented fusion on the patient at (b)(6) hospital. When using the modified pedicle awl with sleeve, the tip was damaged. The nurse informed the dr. That she was unsure if the tip had come off in the patient as she did could not find it. The dr. Was not concerned with this and on the x-ray taken at the completion of the procedure, no tip or fragment was seen. No delay was experienced. The awl has been tagged for repair and is currently at the hospital. The surgeon completed the procedure, the damaged awl was not used again. Patient status/ outcome / consequences are unknown. This complaint involves one (1) device. This report is 1 of 1 for (b)(4).
 
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Brand NameUNKNOWN AWLS
Type of DeviceEXPEDIUM® VERSE SPINE SYSTEM
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 Key9417535
MDR Text Key185304759
Report Number1526439-2019-52587
Device Sequence Number1
Product Code HWJ
Combination Product (y/n)N
Reporter Country CodeAS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 11/12/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/05/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberUNK AWLS
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 Received11/12/2019
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?
Type of Device Usage Unkown

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