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

Model Number 283910000

Device Problem Migration or Expulsion of Device (1395)

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

Event Date 01/01/2020

Event Type  malfunction  

Manufacturer Narrative

Event occurred on an unknown date in 2020.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Reporter is (b)(6).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

Device report from synthes reports an event in (b)(6) as follows: it was reported on (b)(6) 2020 that during an unknown procedure, the confidence spinal cement system syringe leaked and could not be used normally.There was no patient consequence.The procedure outcome is unknown.There is no further information available.This report is for one (1) confidence spinal cmt sys, 11c.This is report 1 of 1 for (b)(4).

Manufacturer Narrative

No conclusions could be drawn as no devices were returned for manufacturer review or investigation.Additionally, device history record reviews could not be requested as specific part and lot numbers for the associated devices were not provided.H3, h6: the device history record (dhr) of product code: 283910000; lot : 279657 was electronically reviewed and no non-conformances were observed during the manufacturing process.The product was released on: may 07, 2020.Visual inspection: the confidence spinal cmt sys, 11c was received at us customer quality (cq).Visual inspection of the complaint device showed one of the introducer needles had broken at the distal tip.Functional test: a functional assessment was performed on the complaint device.The syringe component had pressure applied and released and no leak was identified.The complaint was not able to be replicated.Dimensional inspection: a dimensional inspection was not performed due to post-manufacturing damage.Document/specification review: current and manufactured revisions were reviewed.No design issues or discrepancies were identified.Investigation conclusion: this complaint is not confirmed as no leak was identified.However, one of the introducer needles had broken at the distal tip.No definitive root cause could be determined based on the provided information.There was no indication that a design or manufacturing issue contributed to the complaint.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.No conclusions could be drawn as no devices were returned for manufacturer review or investigation.Review of manufacturing records has been requested.

• 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: 11007700
• MDR Text Key: 229530770
• Report Number: 1526439-2020-02405
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 11/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2020
• 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: 279657
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/26/2021
• Date Manufacturer Received: 04/26/2021
• Patient Sequence Number: 1