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

Catalog Number 183901001

Device Problem Migration or Expulsion of Device (1395)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/09/2021

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).Device available for evaluation: complainant part is expected to be returned for manufacturer review/investigation but has yet to be received.Device evaluated by mfr: without a lot number, the device history records review could not be completed as no product was received.Investigation summary: photo investigation: the product involved in the complaint was not returned for investigation.So, a photo investigation was completed on the images provided.Only the exterior of the high viscosity cmw spinal cement package was pictured, and it could not be confirmed that there was any leakage with the cement package from this.Hence, the complaint will not be confirmed.According to franchise complaint product investigation procedure, a manufacturing record evaluation was not done because a manufacturing issue was not suspected.As the device was not returned, an as-received condition could not be assessed, and a dimensional inspection and document/specification review were not completed.Conclusion: the complaint condition cannot be confirmed based on the image provided.During the investigation, no product design issues, or discrepancies were observed.No manufacturing issues were noted during investigation.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Therefore, it has been determined that no corrective and/or preventive action is proposed.Device history review a manufacturing-related potential cause was not suspected, therefore, per franchise complaint product investigation procedure, no manufacturing record evaluation is required.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 that on (b)(6) 2021, the patient underwent for a procedure.During the procedure, confidence cement was leaking abnormally.It was unknown if the procedure completed successfully.There was no patient consequence.This complaint involves two (2) devices.This report is for (1) high visc cmw spinal cmt, 11cc.This report is 2 of 2 for (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, h6: a product investigation was conducted.Visual inspection: the high viscosity cement was inside the cement reservoir when it was returned to cq west chester for investigation.The cement has solidified inside the syringe.In the image a crack on the hydraulic pump tubing was marked indicating the leakage was from the pump and not the cement.No other issues were identified.Functional test: the functional test was not performed as it was irrelevant to the complaint condition and the cement had solidified inside the reservoir.The complaint condition cannot be replicated.Dimensional inspection: dimensional inspection could not be done on the high viscosity cement.Document/specification review: since the date of manufacture was not available, the current version of the specifications for the cement were reviewed.The complaint cannot be confirmed based on the available information.Conclusion: the plastic tubing connecting the hydraulic pump to the cement reservoir had a crack on its surface hence the high viscosity cement was left inside the reservoir.There were no issues identified with the cement during investigation, hence the complaint could not be confirmed.There was no indication that a design or manufacturing issue contributed to the complaint.No design issues were observed during the document/specification review.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.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: 12181998
• MDR Text Key: 264979860
• Report Number: 1526439-2021-01423
• 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: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 06/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/16/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 183901001
• Device Lot Number: 9647088
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/23/2021
• Date Manufacturer Received: 08/23/2021
• Patient Sequence Number: 1
• Treatment: CONFIDENCE SPINAL CMT SYS, 11C