MAUDE Adverse Event Report: DEPUY SPINE INC 5.5 EXP VERSE FEN SCR 6.0X45; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number	199723645S
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	11/17/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional product codes: kwq and kwp.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 or Problem Description
Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2021, the patient underwent the posterior spinal fusion (t12: fracture, 1a1b, intervertebral fusion: t11~l1) for the osteoporotic compression fracture.The cement was injected to reinforce the screws.The amount of cement was 1.5 ml at t11 and 3.0 ml at l1.The surgery was completed successfully without any surgical delay.On (b)(6) 2021, kyphosis of the spine and vertebral body fracture were confirmed during consultation.The patient has parkinson's disease.He also reported that he had fallen on his behind.The surgeon commented in his opinion, the screw would have been loosened normally when it was subjected to kyphotic force due to parkinson's disease, but this time, it was reinforced with cement, so stress concentrated on the vertebral body and it broke.The likely cause of this was the patient's bone quality and short fusion range, as well as cement injection volume (difference in cement injection volume between the apical and caudal vertebral bodies) and external stress (fall).At present, no symptoms have developed, but if left untreated, neurological symptoms may develop.Therefore, it is desirable to remove the screw, but since the patient suffers from parkinson's disease, revision or conservative treatment may be considered, and the future treatment method has not been determined yet.This report is for an exepedium verse fenestrated screw.This is report 1 of 1 for (b)(4).This report captures the broken screw.Related complaint (b)(4) captures the cement.

• Brand Name: 5.5 EXP VERSE FEN SCR 6.0X45
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• 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: 13046842
• Report Number: 1526439-2021-02598
• Device Sequence Number: 1750896
• Product Code: NKB
• UDI-Device Identifier: 10705034443515
• UDI-Public: (01)10705034443515
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K173095
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 199723645S
• Device Catalogue Number: 199723645S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/26/2021
• Initial Report FDA Received Date: 12/20/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 72 YR
• Patient Sex: Male