MAUDE Adverse Event Report: ZIMMER TMT TM ARDIS® INTERBODY SYSTEM SOLID; PROSTHESIS, SPINE

Catalog Number 0670201071

Device Problems Loose or Intermittent Connection (1371); Migration or Expulsion of Device (1395); Device Dislodged or Dislocated (2923)

Patient Problems Failure of Implant (1924); No Information (3190)

Event Date 07/16/2019

Event Type  Injury  

Manufacturer Narrative

Investigation in progress.

Event Description

Zimmer biomet (b)(4) reported the patient underwent revision surgery on (b)(6) 2019 for neuropathy because the tm cage had backed out.After the removal, it was found the plugs on both sides of the s was loose.The original surgery took place on (b)(6) 2019 for l2-s spinal fixation.Revision surgery was delayed for 20 minutes.

Event Description

No further event information available at the time of this report.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Concomitant medical products: 0670201071, tm ardisâ® interbody system solid, lot # 63392062.Event occurred in japan.Multiple mdr reports were filed for this event, please see associated reports: 3005751028-2019-00039.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Reported event was unable to be confirmed due to limited information received from the customer.No devices or medical records were received.Device history record (dhr) was reviewed and no discrepancies were found.Root cause was unable to be determined.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

No further event information available at the time of this report.

• Brand Name: TM ARDIS® INTERBODY SYSTEM SOLID
• Type of Device: PROSTHESIS, SPINE
• Manufacturer (Section D): ZIMMER TMT; 10 pomeroy road; parsippany NJ 07054
• MDR Report Key: 8873370
• MDR Text Key: 162011926
• Report Number: 3005751028-2019-00017
• Device Sequence Number: 1
• Product Code: ODP
• Combination Product (y/n): N
• PMA/PMN Number: NOT CLEARED
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup,Followup
• Report Date: 01/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2023
• Device Catalogue Number: 0670201071
• Device Lot Number: 63922450
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 74 YR