MAUDE Adverse Event Report: K2M, INC. PLATE, 1 LEVEL; SIZE 36 MM; APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Model Number	AA01-41F36V
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/26/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device was disposed of by hospital.
Event or Problem Description
It was reported that the locking cap of an ozark plate 'broke off while final locking' intra-operatively.There were no adverse consequences to the patient.The procedure was completed successfully using an alternatively available implant with a 15 minute surgical delay.
Additional Manufacturer Narrative
Visual, dimensional, material and functional analysis could not be performed as the device was not returned.  device and complaint history records review could not be performed as a valid lot code was not provided and could not be obtained.Potential trend evaluation: a review of complaint history associated with the subject catalog number was performed, and no complaints for the catalog# were identified.Therefore, no adverse trends were observed.Ozark view and guide surgical technique was reviewed and the following relevant information was identified: engage lock the ozark plates feature an integrated titanium alloy locking cover to prevent screw back out.After screw insertion, engage the locking cover by inserting the size 10 tapered driver into the screw cover and rotating clockwise 90 so that the cover retains the screw heads.Screws should sit below the screw cover to ensure that the locking cover is adequately engaged.Note: plate geometry should prevent the locking cover from rotating beyond the intended 90.Do not rotate the locking cover past the clockwise stop on the plate.Screw realignment or removal if screw realignment or removal is necessary, use the size 10 tapered driver to rotate the screw cover 90 counter-clockwise so that the locking cover no longer covers any part of the screw.Continue to remove the screw with the size 10 tapered driver attached to the spin top handle, or the size 10 threaded driver attached to the torque limiting handle, 12 in-lbs.Per correspondence with sales rep, "the screws were inserted at a difficult angle making it hard to lock".This could have contributed to the event.However, since the device was not returned, an exact cause of the reported event could not be determined.
Event or Problem Description
It was reported that the locking cap of an ozark plate 'broke off while final locking' intra-operatively.There were no adverse consequences to the patient.The procedure was completed successfully using an alternatively available implant with a 15 minute surgical delay.

• Brand Name: PLATE, 1 LEVEL; SIZE 36 MM
• Common Device Name: APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
• Manufacturer (Section D): K2M, INC.; 600 hope parkway se; leesburg VA 20175
• MDR Report Key: 11720771
• Report Number: 3004774118-2021-00120
• Device Sequence Number: 4027149
• Product Code: KWQ
• UDI-Device Identifier: 10888857401457
• UDI-Public: 10888857401457
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K172104
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: AA01-41F36V
• Device Catalogue Number: AA01-41F36V
• Device Lot Number: UNKOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/26/2021
• Supplement Date Received by Manufacturer: 06/30/2021
• Initial Report FDA Received Date: 04/23/2021
• Supplement Report FDA Received Date: 07/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1