MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH CONFIDENCE SPINAL CMT SYS, 11C; POLYMETHYLMETHACRYLATE BONE CEMENT

Model Number 283910000

Device Problem Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/02/2019

Event Type  malfunction  

Manufacturer Narrative

If the information is unknown, not available or does not apply, the section/field of the form is left blank.Complainant part is not expected to be returned for manufacturer review/investigation.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.

Event Description

It was reported that during a posterior spinal fusion on (b)(6) 2019, after mixing a confidence cement system and getting ready to implant it through verse fenestrated screws, the surgeon realized the hydraulic pump was defective.Water was freely flowing within both sides of the pump, despite the rubber barrier that is supposed to keep it in one side.The surgeon had only implanted a small amount of cement at this point.He removed the cement system and cannula from the screw and discarded the pump.No water leaked out of the pump into the patient.The procedure was completed successfully with a five (5) minute delay.There was no patient harm/consequence.This report is for a confidence spinal cement system.This is report 1 of 1 for (b)(4).

Manufacturer Narrative

Product complaint (b)(4).Udi: (b)(4).H4, h6: additional information.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.The complaint device was not received for investigation.The following investigation is based on the image(s) provided.The image(s) was reviewed, and the complaint condition could not be confirmed because the water flow inside the hydraulic pump cannot be visualized in the provided image.Since the device was not returned, a dimensional inspection and a functional test were not able to be performed.A review of the device history record was conducted.No issues were identified during the manufacturing and release of this product that could have contributed to the problem reported by the customer.A definitive assignable root cause could not be determined based on the provided information.During the investigation, no product design issues or discrepancies were observed (based on the images) that may have contributed to the complaint condition.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.

• Brand Name: CONFIDENCE SPINAL CMT SYS, 11C
• 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: 9530014
• MDR Text Key: 175728213
• Report Number: 1526439-2019-52804
• Device Sequence Number: 1
• Product Code: NDN
• UDI-Device Identifier: 10705034209623
• UDI-Public: (01)10705034209623
• Combination Product (y/n): N
• PMA/PMN Number: K060300
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 12/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 283910000
• Device Catalogue Number: 283910000
• Device Lot Number: 250171
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/14/2020
• Patient Sequence Number: 1
• Patient Age: 78 YR