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

Model Number 283910000

Device Problems Device Damaged Prior to Use (2284); Failure to Eject (4010)

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

Event Date 09/02/2020

Event Type  malfunction  

Manufacturer Narrative

Initial reporter is a synthes employee the device history record (dhr) of product code 283910000, lot 281083 was electronically reviewed and there were no non-conformance reports observed during the manufacturing process that would have a link with complaint description.The product was released on: may 27, 2020.A product investigation was completed: upon visual inspection, it was observed that the cement was hardened inside the cement reservoir and there was some hardening liquid inside the pump and the reservoir.The tip of the reservoir was observed to be deformed and broken.No other issues were identified with the returned device that could impact the device functionality.The connector was not able to connect/disconnect from the reservoir and the functional test was failed to perform on the returned device as the cement was solidified.A dimensional inspection was not performed as the complaint relevant tip dimensions cannot be checked for dimensional accuracy, because of the received, damaged condition.Based on the date of manufacture, the current and manufactured revision of drawings were reviewed.The complaint condition was confirmed.Even though the cement delivery was not tested because of the appropriate solidified state of the cement, the damaged condition of the tip could have contributed to a functional issue.There is no indication that a design or manufacturing issue has caused the issue and hence the root cause cannot be determined.The possible cause could be due to unintended forces applied to the device and the cement may have solidified prematurely due to environmental factors that might have an impact on the cement¿s setting time.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.

Event Description

Device report from synthes (b)(6) reports an event as follows: it was reported the tip was bent so the cement could not be extruded.No consequence to the patient was reported.During the investigation by the manufacturer, it was noted that the tip of the reservoir was observed to be deformed and broken.This report is for a confidence spinal cement system.This is report 1 of 1 for (b)(4).

• Brand Name: CONFIDENCE SPINAL CMT SYS, 11C
• Type of Device: CEMENT, BONE, VERTEBROPLASTY
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• Manufacturer Contact: kara ditty-bovard ; chemin-blanc 38; le locle 02400 ; SZ 02400 ; 6103142063
• MDR Report Key: 10935218
• MDR Text Key: 219197023
• Report Number: 1526439-2020-02334
• Device Sequence Number: 1
• Product Code: NDN
• UDI-Device Identifier: 10705034209623
• UDI-Public: (01)10705034209623
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: K060300
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 281083
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/25/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/01/2020
• Initial Date FDA Received: 12/02/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/27/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1