MAUDE Adverse Event Report: ZIMMER TMT TM ARDIS INTERBODY SYSTEM; METALLIC SPINAL INTERBODY FUSION CAGE

Model Number	N/A
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/04/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Report source: foreign country: (b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
Implant migrated 10% after 6weeks post op follow up.Implant tm ardis with size 9*26*11 was inserted in level l5,s1.Implant remains on patient.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.No product was returned; visual and dimensional evaluations could not be performed.Review of the device history record(s) identified no deviations or anomalies during manufacturing.The device is used for treatment.Review of complaint history identified (1) additional similar complaints for the reported item/lot combination.Complaints are monitored through monthly complaint review (reference os 5017) in order to identify potential adverse trends.Medical images were provided and reviewed by a health care professional.Review of the available records identified the following: lateral film of the lumbar spine dated (b)(6) 2020 and (b)(6) 2021 demonstrate posterior fusion hardware at l4-l5 with bilateral pedicle screw and rod fixation.Intervertebral disc implant is noted at the l5-s1 disc space and appears to move posteriorly on the follow-up film by approximately 20% a definitive root cause cannot be determined.No corrective actions, preventive actions, or field actions resulted after investigation of this event.

• Brand Name: TM ARDIS INTERBODY SYSTEM
• Common Device Name: METALLIC SPINAL INTERBODY FUSION CAGE
• Manufacturer (Section D): ZIMMER TMT; 10 pomeroy road; parsippany NJ 07054
• MDR Report Key: 11545055
• Report Number: 3005751028-2021-00018
• Device Sequence Number: 4140459
• Product Code: MAX
• UDI-Device Identifier: 00889024315778
• UDI-Public: (01)00889024315778(17)220331(10)63600164
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• PMA/510(K) Number: K113561
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2022
• Device Model Number: N/A
• Device Catalogue Number: 0670102111
• Device Lot Number: 63600164
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/04/2021
• Supplement Date Received by Manufacturer: 06/16/2021
• Initial Report FDA Received Date: 03/22/2021
• Supplement Report FDA Received Date: 06/17/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization