MAUDE Adverse Event Report: DEPUY SPINE INC UNKNOWN LOCKING/SET SCREWS; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

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 set screws/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 set screws.This is report 3 of 3 for (b)(4) and captures the adjacent segment disease.The broken screw is captured under (b)(4).

• Brand Name: UNKNOWN LOCKING/SET SCREWS
• Type of Device: THORACOLUMBOSACRAL 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 Key: 10815934
• MDR Text Key: 215490305
• Report Number: 1526439-2020-02134
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• 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 Received: 11/10/2020
• 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
• Date Manufacturer Received: 10/13/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: UNKNOWN RODS; UNKNOWN SCREWS
• Patient Outcome(s): Required Intervention