MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH HIGH VISC CMW SPINAL CMT, 11CC; POLYMETHYLMETHACRYLATE BONE CEMENT

Catalog Number 183901001

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

Patient Problems Pain (1994); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Reporter is jnj representative.Without a lot number, the device history records review could not be completed as no product was received.The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.(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.

Event Description

Device report from synthes reports an event in (b)(6) as follows: it was reported on an unknown date that the patient underwent for a surgery to extend the stabilization to the l5-s1 level on (b)(6) 2017.Previously operated procedure was done one (b)(6) 2017 without any complications, but the patient¿s disease started to progress and the l5-s1 level was taken.During this procedure, two additional screws were screwed into the pelvis, the bars were replaced with longer ones and the cage concord was inserted at the l5-s1 level.The procedure was completed successfully without any delay reported.The patient was discharged from the hospital.This complaint involves unknown number of devices.This report is for (1) high visc cmw spinal cmt, 11cc.This is report 1 of 4 (b)(4).Related product 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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H3, h4, h6: a review of the receiving inspection (ri) for high visc cmw spinal cmt, 11cc was conducted identifying that lot number 8690369 was released in a single batch on (b)(6) 2017 with no discrepancies.As a result, the ri identified no issues during the manufacturing and release of this device that could have contributed to the problem reported by the customer.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.H10 additional narrative: d10: complainant part is not expected to be returned for manufacturer review/investigation.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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10: additional narrative: d4: lot number.H3, h4, h6: a review of the receiving inspection (ri) for high visc cmw spinal cmt, 11cc was conducted identifying that lot number 8690369 was released in a single batch on march 09, 2018 with no discrepancies.As a result, the ri identified no issues during the manufacturing and release of this device that could have contributed to the problem reported by the customer.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: HIGH VISC CMW SPINAL CMT, 11CC
• Type of Device: POLYMETHYLMETHACRYLATE BONE CEMENT
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 10477240
• MDR Text Key: 205277011
• Report Number: 1526439-2020-01582
• Device Sequence Number: 1
• Product Code: NDN
• Combination Product (y/n): N
• PMA/PMN Number: K112907
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 08/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 183901001
• Device Lot Number: 8690369
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/05/2020
• Patient Sequence Number: 1
• Treatment: UNKNOWN CAGE/SPACER; UNKNOWN RODS; UNKNOWN SCREWS
• Patient Outcome(s): Required Intervention