MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH EXPEDIUM VERSE SPINE SYSTEM FENESTRATED CORTICAL FIX POLYAXIAL SCREW 7.0 X 45MM; APPLIANCE, FIXATION, SPINAL INTERLAMINAL

Model Number 199723745S

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

Patient Problems Low Blood Pressure/ Hypotension (1914); Embolism/Embolus (4438)

Event Date 09/05/2022

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 (t10 to l5) for the secondary polytrauma on (b)(6) 2022.L1 and l2 were the vertebral trauma, and l4 was the obsolete compression fracture.L1 and l2 barely had centrums, and it was a surgery to gain posterior support with the verse fenestrated screws in question.Since the patient was elderly, a vertebral body replacement was not performed.The events took place as follows: the screw in question was inserted into t10 as per surgical technique.The ha sticks were inserted into t11 to l2 as per surgical technique.The screw in question was inserted into l5, and the cement was mixed.The screw in question was inserted into l4 while mixing the cement.The cement was inserted into the screw in question before the screw was inserted into l3.The cement was inserted into l5 and t10.There was no cement leakage.After the cement was inserted into the screws in question, the blood pressure dropped rapidly.The heart and lungs were in a state of pause.After the wound was closed, the cardiopulmonary system returned.The hypotension had not improved.The surgery was completed successfully without any surgical delay.After the surgery, it was confirmed by the ct that there was no cement leakage.The abnormalities were found in the cardiopulmonary and arteries.The surgeon suspected it as a fat embolus.The blood pressure remains low, and the patient is on a vasopressor.No further information is available.This report involves one expedium verse spine system fenestrated cortical fix polyaxial screw 7.0 x 45mm.This is report 3 of 4 for (b)(4).(b)(4) and (b)(4) are involved with the same event.(b)(4) (depuy spine): screw.(b)(4) (synthes 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.Additional product codes: kwq, nkb.The investigation could not be completed; no conclusion could be drawn, as no product was received.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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H4 device history a manufacturing record evaluation was performed for the finished device product code: 199723745s, lot number: 333950.It was electronically reviewed and no non-conformances / manufacturing irregularities were identified during the manufacturing process.The product was released on: 15/02/2022 qty: (b)(4).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: EXPEDIUM VERSE SPINE SYSTEM FENESTRATED CORTICAL FIX POLYAXIAL SCREW 7.0 X 45MM
• Type of Device: APPLIANCE, FIXATION, SPINAL INTERLAMINAL
• 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: 15478148
• MDR Text Key: 300563483
• Report Number: 1526439-2022-01671
• Device Sequence Number: 1
• Product Code: KWP
• UDI-Device Identifier: 10705034444505
• UDI-Public: 10705034444505
• 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,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 199723745S
• Device Catalogue Number: 199723745S
• Device Lot Number: 333950
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/01/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/15/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: UNKNOWN BONE CEMENT
• Patient Outcome(s): Required Intervention
• Patient Age: 87 YR
• Patient Sex: Female