MAUDE Adverse Event Report: DEPUY SPINE INC EXP DUAL-INNER SETSCREW; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD

Model Number 179722000

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Osteolysis (2377)

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).Additional product code: kwp; kwq; mnh; mni; osh.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.The investigation could not be completed, no conclusion could be drawn at the time of filing this report.The 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.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 an unknown date, the patient had suffered from the adjacent disease.On (b)(6) 2021 a revision surgery was performed without further issue.The primary procedure was performed in 2008 and expedium di was applied.This complaint involves twenty (20) devices.This report involves one (1) exp dual-inner set screw.This is report 7 of 20 for (b)(4).

• Brand Name: EXP DUAL-INNER SETSCREW
• Type of Device: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• Manufacturer (Section G): SENTIO (INNOVATIVE SURGICAL SOLUTIONS, LLC); 50461 west pontiac trail; wixom MI 48393
• Manufacturer Contact: kara ditty-bovard ; 325 paramount drive; raynham, MA 02767 ; 6103142063
• MDR Report Key: 12373629
• MDR Text Key: 268342063
• Report Number: 1526439-2021-01767
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 10705034070070
• UDI-Public: 10705034070070
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K160904
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 179722000
• Device Catalogue Number: 179722000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/30/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: EXP DI POLYAXL SCRW 6 X 40 MM; EXP DI POLYAXL SCRW 6 X 40 MM; EXP DI POLYAXL SCRW 6 X 40 MM; EXP DI POLYAXL SCRW 6 X 40 MM; EXP DI POLYAXL SCRW 6 X 40 MM; EXP DI POLYAXL SCRW 6 X 40MM; EXP DUAL-INNER SET SCREW; EXP DUAL-INNER SET SCREW; EXP DUAL-INNER SET SCREW; EXP DUAL-INNER SET SCREW; EXP DUAL-INNER SET SCREW; LUMBAR I/F CAGE 9 X 21 MM; LUMBAR I/F CAGE 9 X 21 MM; LUMBAR I/F CAGE 9 X 21 MM; LUMBAR I/F CAGE 9 X 21 MM; LUMBAR I/F CAGE 9 X 21 MM; ROD, 120 MM; ROD, 120 MM; ROD, 480 MM; TI TRANSVERSE CONNECTOR
• Patient Outcome(s): Required Intervention