MAUDE Adverse Event Report: K2M, INC. PLATE, 5 LEVEL; SIZE 100 MM; APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Model Number	AA01-45F100V
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/04/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
A physician reported that two ozark screws at c7 migrated and the securing mechanism of the five-level ozark plate fractured at the same level.The patient was revised.This record captures the five-level ozark plate.
Event or Problem Description
A physician reported that two ozark screws at c7 migrated and the securing mechanism of the five-level ozark plate fractured at the same level.The patient was revised.This record captures the five-level ozark plate.
Additional Manufacturer Narrative
Visual inspection: upon review of the provided image, the construct was composed five (5) level plate, twelve (12) screws, and chesapeake interbodies.The construct spanned from c2-c7.The locking cover fractured and the screw migrations were confirmed to have occurred bilaterally, at the caudal-most level of the construct (c7).The screws were approximately 3.6mm proud.The explanted locking cover was returned for inspection- it was observed that the stem/swage fractured off of the cover.The explanted screws were not returned.Device history records review could not be performed as a valid lot code was not provided and could not be obtained.Complaint history records could not be reviewed for this lot as the lot number could not be obtained, however, a review for the catalog number was performed and no similar complaints were identified.Correspondence with rep states that it is not known if the patient was fusing.Incidences of this nature can be multifactorial.Upon review of the provided x-ray, it is possible that the interbody at c6-c7 could potentially be contacting the plate, which can create unanticipated loading.However, the positioning of the interbody could not be confirmed based on the provided image views.The integrity of the construct could have also been influenced by the number of levels instrumented.The use of a larger construct could have created an increase of dynamic loading at the caudal levels, contributing to the observed fracture and migration at c7.However, based on the available information, the cause of the reported event could not be established conclusively.

• Brand Name: PLATE, 5 LEVEL; SIZE 100 MM
• Common Device Name: APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
• Manufacturer (Section D): K2M, INC.; 600 hope parkway se; leesburg VA 20175
• MDR Report Key: 11608627
• Report Number: 3004774118-2021-00090
• Device Sequence Number: 4009470
• Product Code: KWQ
• UDI-Device Identifier: 10888857402836
• UDI-Public: 10888857402836
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K172104
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/27/2021

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 Model Number: AA01-45F100V
• Device Catalogue Number: AA01-45F100V
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/19/2021
• Initial Date Received by Manufacturer: 03/04/2021
• Supplement Date Received by Manufacturer: 06/30/2021
• Initial Report FDA Received Date: 04/02/2021
• Supplement Report FDA Received Date: 07/28/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Weight: 230