MAUDE Adverse Event Report: KYOCERA MEDICAL TECHNOLOGIES, INC. TESERA; ALIF CAGE

Model Number Tesera

Device Problems Detachment of Device or Device Component (2907); Device Dislodged or Dislocated (2923); Unintended Movement (3026)

Patient Problem Failure of Implant (1924)

Event Date 05/12/2020

Event Type  malfunction  

Manufacturer Narrative

The initial surgery was completed on (b)(6) 2020.The complaint was reported to kmti after a routine follow-up examination (approximately 6 weeks).An x-ray image revealed cage subsidence, a dislodged locking cover plate, and partially expelled screws in the superior level of a two-level surgery (l3-l4, l4-l5).The following parts were used in the initial surgery: catalog number: 1031-383-015, lot #: 10788-5, description: s128 alif 38x30 - 15mm height cage 7 degree lordosis.1031-383-013, 13057-1, s128 alif 38x30 - 13mm height cage 7 degree lordosis.1028-003-001, 13286-3, alif locking cover plate.1028-003-001, 13286-1, alif locking cover plate.1028-453-225, 11038-4, alif variable angle hex screw.1028-453-225, 11037-7, alif variable angle hex screw.1028-453-225, 11038-3, alif variable angle hex screw.The implants will likely not be returned to kmti for investigation.From the 6-week follow up x-ray image and the sales sheet for the surgery, the following information can be gathered: the surgery was performed on two levels (l3-l4, l4-l5).Based on the x-ray images taken at the time of surgery, it appears the screws were properly seated in the cages and the locking cover plates were properly attached.Only the superior construct appears damaged.The superior cage appears to have subsided into l3 and l4.The subsidence has reduced the angle in the sagittal plane for all 4 screws.The superior screws have expelled a few millimeters from the front of the cage.The locking cover plate has dislodged.The dislodged locking cover plate appears incomplete (fractured or obscured).The superior cage is the taller of the two cages (15mm).The lot histories for the involved devices were reviewed and no deviations that would affect the parts were identified.The most probable cause is determined to be excessive force on the cover plate and screws caused by relative motion between the cage and screws as the cage subsided.The cage appears to have subsided into both the inferior and superior vertebrae.As the cage subsided and moved relative to the endplates, the screws did not move by the same amount.The resulting forces caused the superior screws to load the locking cover plate and the load was sufficient to fracture and dislodge the cover plate.

Event Description

During a 6 week routine follow-up examination on (b)(6) 2020, an x-ray image revealed cage subsidence, a dislodged locking cover plate, and partially expelled screws in the superior level of a two-level surgery (l3-l4, l4-l5).

• Brand Name: TESERA
• Type of Device: ALIF CAGE
• Manufacturer (Section D): KYOCERA MEDICAL TECHNOLOGIES, INC.; 1200 california st.; ste 210; redlands, ca
• Manufacturer (Section G): KYOCERA MEDICAL TECHNOLOGIES; 1200 california st.; redlands, ca
• Manufacturer Contact: anthony debenedictis ; 1200 california st; ste 210; redlands, ca ; 5572360451
• MDR Report Key: 10084346
• MDR Text Key: 193942144
• Report Number: 3015398319-2020-00001
• Device Sequence Number: 1
• Product Code: OVD
• UDI-Device Identifier: 00841523100361
• UDI-Public: (01)00841523100361(17)230102(10)10788-5
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K140106
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 05/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/02/2023
• Device Model Number: Tesera
• Device Catalogue Number: 1031-383-015
• Device Lot Number: 10788-5
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/12/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/14/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other