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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY SPINE INC UNKNOWN RODS THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

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DEPUY SPINE INC UNKNOWN RODS THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Injury (2348); Osteolysis (2377)
Event Type  Injury  
Manufacturer Narrative

510k: this report is for unknown rods/unknown lot. Part and lot number are unknown; udi 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. 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 (b)(6) reports an event as follows: it was reported that on (b)(6) 2020, a l4-s1 posterior lumbar interbody fusion (plif) was extended to l3-s1 due to adjacent segment disease. Upon extension, it was discovered that the left s1 screw was broken. The shaft was left in situ and the head removed. A new left s1 screw was placed next to the old screw shaft. Procedure was successfully completed with a ten (10) minutes delay. There was no patient consequence. This report is for unknown rods. This is report 2 of 3 for (b)(4) and captures the adjacent segment disease. The broken screw is captured under (b)(4).

 
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Brand NameUNKNOWN RODS
Type of DeviceTHORACOLUMBOSACRAL PEDICLE SCREW 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 Key10815898
MDR Text Key215482506
Report Number1526439-2020-02133
Device Sequence Number1
Product Code NKB
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 OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial
Report Date 10/13/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/10/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
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 Received10/13/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown

Patient TREATMENT DATA
Date Received: 11/10/2020 Patient Sequence Number: 1
Treatment
UNKNOWN LOCKING/SET SCREWS; UNKNOWN SCREWS
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