MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH VIPER PRIME CFX FEN X-TAB POLYAXIAL SCREW 5.5 7 X 50MM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Catalog Number 186770450S

Device Problems Break (1069); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Pulmonary Embolism (1498)

Event Date 09/21/2023

Event Type  Injury  

Event Description

Device report from synthes reports an event in japan as follows: it was reported that this was a spinal fusion of the thoracolumbar spine and percutaneous vertebroplasty of the thoracic vertebrae (th9-l2) for a thoracolumbar vertebral fracture on (b)(6) 2023.The surgery was performed according to the normal surgical technique as follows: 10 prime fs were inserted into th9, th10, th11-l1, and l2.After setting vbs at th12, the cement was injected into 4 screws at th9 and l2.2 screws were inserted into th12.Rods were measured and set, the final tightening was done, tabs were broken off, and the wound closure was proceeded.There was nothing unusual during the surgery, but the patient's blood pressure suddenly decreased during wound closure.Immediately after the wound was closed, the surgeon changed the patient's position to the supine position and waited for a while until the patient's condition calmed down.The surgery was completed with no surgical delay.The surgeon commented that pulmonary embolism may have occurred due to cement injection and he will conduct tests and make a diagnosis.In addition to product defects, another possible cause is poor patient condition.No further information is available.Remarks: (b)(4) are involved with the same event.(b)(4) (synthes spine): cement.(b)(4) (depuy spine): screw.This report is for one (1) unk - screws: viper prime.This is report 4 of 4 for complaint: (b)(4).

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.H10 additional narrative: d1, d2, d3, d4, g5 ¿ 510k: this report is for an unk - screws: viper prime lot.Part and lot numbers are unknown; udi number is unknown.D9: complainant part is not expected to be returned for manufacturer review/investigation.E1: (b)(6).E3: reporter is a j&j employee.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.

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.H10 additional narrative: d2: additional procodes: kwq, kwp.A manufacturing record evaluation was performed for the finished device product code: 186770450s lot number# tbalei it was electronically reviewed and no nonconformances / manufacturing irregularities were identified during the manufacturing process.The product was released on: 28/04/2023.Manufacturing site: jabil le locle.Expiry date: 31/03/2028.Product was not returned.Based on the information available, it has been determined that no corrective and 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.If information is obtained that was not available for this medwatch, a follow-up medwatch will be filed as appropriate.

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: b5 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.H6: health effect - impact code.

Event Description

Upon examination after surgery, the surgeon commented that this event had no causal relationship to the cement and was not caused by the surgical technique.The surgeon also commented that this event appears to have been caused by blood clot embolism in the lower limbs, and the patient is currently in stable condition, having been placed on an ecmo and trying to rest.

• Brand Name: VIPER PRIME CFX FEN X-TAB POLYAXIAL SCREW 5.5 7 X 50MM
• Type of Device: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• Manufacturer (Section G): MEDOS INT SPINE; chemin blanc 38; le locle ; SZ
• Manufacturer Contact: kate karberg ; chemin-blanc 38; le locle ; SZ ; 3035526892
• MDR Report Key: 17905389
• MDR Text Key: 325337840
• Report Number: 1526439-2023-01985
• Device Sequence Number: 1
• Product Code: NKB
• 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: Physician
• Type of Report: Initial,Followup,Followup
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 10/10/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 186770450S
• Device Lot Number: TBALEI
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/22/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/28/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 83 YR
• Patient Sex: Female