MAUDE Adverse Event Report: DEPUY SPINE INC VIPER PRIME CFX FEN X-TAB POLYAXIAL SCREW 5.5 4.5 X 40MM; APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Catalog Number 186745440S

Device Problems Entrapment of Device (1212); Device-Device Incompatibility (2919)

Patient Problems Foreign Body In Patient (2687); Insufficient Information (4580)

Event Date 01/29/2024

Event Type  malfunction  

Event Description

Device report from synthes reports an event in japan as follows: this pc is related to (b)(4) which reports the revision surgery occurred after the initial surgery.This pc reports the screw removal difficulty occurred in the revision surgery.It was reported an initial posterior spinal fusion procedure was performed on (b)(6) 2023, with the screws in question.L2: vbs l1-4: primefs after the initial surgery, the revision surgery was performed on (b)(6) 2024, to remove and replace to other company¿s screws and to extend the fusion range to the head side.The cause for the revision is unknown.Patient is stable in the revision surgery, an event occurred where the l1 left screw in question could not be removed.Percutaneous extraction was attempted using a screwdriver, but the lower hole inside the vertebral arch root was loose and the screw and cement were idling in the vertebral body in one lump.There was a proposal to remove the cement mass by hooking it inside the vertebral body while pulling it dorsally and separating the cement from the screw, but this was not implemented for the risk of dislodging the cement mass in the direction of the spinal canal.The surgeon decided not to remove the screw in question and left it in the body, while extending the other company's screws to the head and connecting them.The surgery was completed successfully within 30 minutes surgical delay.No further information is available.This report is for viper prime cfx fen x-tab polyaxial screw 5.5 4.5 x 40mm for (b)(4) remarks: (b)(4) are involved with the same event.(b)(4) (synthes spine): screw.(b)(4) (depuy spine): cement.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: e1: initial reporter is j&j company representative h3, h4, h6: 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.

• Brand Name: VIPER PRIME CFX FEN X-TAB POLYAXIAL SCREW 5.5 4.5 X 40MM
• Type of Device: APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: kate karberg ; 325 paramount drive; raynham, MA 02767 ; 3035526892
• MDR Report Key: 18676165
• MDR Text Key: 335108941
• Report Number: 1526439-2024-00865
• Device Sequence Number: 1
• Product Code: KWQ
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K173095
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 186745440S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/29/2024
• 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
• Patient Age: 84 YR
• Patient Sex: Female