MAUDE Adverse Event Report: K2M, INC. PLATE, 1 LEVEL; SIZE 20 MM; APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Model Number	AA01-41F20V
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/25/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during plate removal at c5-6 due to successful fusion at the current site, the locking mechanism of the ozark plate was no longer attached to the implant post-operatively.A new plate and cage were placed at the level above and the procedure was completed successfully.
Additional Manufacturer Narrative
Hospital retained the device.
Event or Problem Description
It was reported that during plate removal at c5-6 due to successful fusion at the current site, the locking mechanism of the ozark plate was no longer attached to the implant post-operatively.A new plate and cage were placed at the level above and the procedure was completed successfully.
Additional Manufacturer Narrative
Visual, dimensional, material and functional analysis could not be performed as the device was not returned.Device history records could not be reviewed as a valid lot number was not provided and could not be obtained.A review of complaint history associated with the subject catalog number was performed and no adverse trends were observed.Initial report states that as the surgeon was removing the plate from a previous procedure, the locking mechanism was loose and no longer attached to the plate.It was reported via follow up communication that the plate was being removed to add a new plate and cage a level above.It was noted the plate was not bent.The patient fused at the levels of reported plate, c5/6.Ozark view and guide surgical technique was reviewed: note: ¿do not over angulate screws beyond their indicated limit, doing so could result in the inability to lock the cover.¿ ¿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.¿ ¿adequately instruct the patient.Postoperative care and the patient¿s ability and willingness to follow instructions are two of the most important aspects of successful healing.Internal fixation devices are load sharing devices which maintain alignment until healing occurs.If healing is delayed or does not occur the implant could eventually break, bend or loosen.Loads produced by load bearing and activity levels will impact the longevity of the implant.¿.Due to no product return the root cause could not be determined conclusively.Potential root causes include, but are not limited to: patient non compliance, patient trauma, known inherent risk after successful fusion, improper placement of implants, non-union, pseudo, and over angulation of screws.

• Brand Name: PLATE, 1 LEVEL; SIZE 20 MM
• Common Device Name: APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
• Manufacturer (Section D): K2M, INC.; 600 hope parkway se; leesburg VA 20175
• Manufacturer (Section G): K2M, INC.; 600 hope parkway se; leesburg VA 20175
• Manufacturer Contact: rita karan ; 2 pearl court; allendale, NJ 07401 ; 2017608000
• MDR Report Key: 13581291
• Report Number: 3004774118-2022-00069
• Device Sequence Number: 14873021
• Product Code: KWQ
• UDI-Device Identifier: 10888857401297
• UDI-Public: 10888857401297
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 05/23/2022

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: AA01-41F20V
• Device Catalogue Number: AA01-41F20V
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/25/2022
• Supplement Date Received by Manufacturer: 04/27/2022
• Initial Report FDA Received Date: 02/22/2022
• Supplement Report FDA Received Date: 05/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown