MAUDE Adverse Event Report: K2M, INC. CONSTRAINED PLATE, 3 LEVEL; SIZE 63 MM; APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Model Number	208-43F63
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/30/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was observed via x-ray that a pyrenees 3 level constrained plate had fractured.Revision has occurred and the device was replaced.
Event or Problem Description
It was observed via x-ray that a pyrenees 3 level constrained plate had fractured.Revision has occurred and the device was replaced.
Additional Manufacturer Narrative
Visual inspection confirmed the 3 level plate fractured.Fracture occurred across the 2nd or 3rd pair of screw holes.It was not confirmed what level event occurred on or orientation the plate was placed in patient.Wear marks are observed over the anterior surface of the plate.Device and complaint history records were reviewed for this lot, no relevant manufacturing issues or similar complaints were identified.It was reported via follow-up that the patient had achieved fusion which was confirmed in their 4 months post-op follow-up.The device stg/ifu was reviewed and the following was noted as relevant: postoperative -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.-implants can loosen, fracture, corrode, migrate, cause pain, or stress shield bone even after a bone has healed.If an implant remains implanted after complete healing, it can actually increase the risk of refracture in an active individual.The surgeon should weigh the risks versus benefits when deciding whether to remove the implant.Implant removal should be followed by adequate postoperative management to avoid refracture.The root cause was determined to be due to known inherent risk of device.The device was implanted for 8 months and the patient achieved fusion.Therefore, the device performed its intended function.Patient non-compliance and/or trauma may have contributed to the event, but could not be confirmed.

• Brand Name: CONSTRAINED PLATE, 3 LEVEL; SIZE 63 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: 13286151
• Report Number: 3004774118-2022-00022
• Device Sequence Number: 4547464
• Product Code: KWQ
• UDI-Device Identifier: 10888857031180
• UDI-Public: 10888857031180
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K063544
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/29/2022

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: 208-43F63
• Device Catalogue Number: 208-43F63
• Device Lot Number: HAPT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/04/2022
• Supplement Date Received by Manufacturer: 04/01/2022
• Initial Report FDA Received Date: 01/18/2022
• Supplement Report FDA Received Date: 04/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 67 YR
• Patient Sex: Unknown