MAUDE Adverse Event Report: K2M, INC. CONSTRAINED PLATE, 4 LEVEL; SIZE 85 MM; APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Model Number	208-44F85
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/13/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
A physician reported that a patient underwent revision surgery to address a fractured four-level constrained pyrenees plate.
Additional Manufacturer Narrative
Visual inspection confirms the plate is fractured across the middle plate screw holes.The plate is visibly worn, most likely from normal wear and in vivo conditions for eight-months.Device history records were reviewed and no relevant manufacturing issues were identified.Complaint history was reviewed and no similar complaints for the reported lot number were identified.Device stg reviewed: the patient must be made aware of the limitations of the implant and that physical activity and load bearing have been implicated in premature loosening, bending or fracture of internal fixation devices.The patient should understand that an implant is not as strong as a normal, healthy bone and will fracture under normal load bearing in the absence of complete bone healing.An active, debilitated or uncooperative patient who cannot properly restrict activities may be at particular risk during postoperative rehabilitation.Potential risks identified with the use of this device system which may require additional surgery include device component failure, loss of fixation, non-union, fracture of the vertebra, and neurological, vascular or visceral injury.The implants are intended to provide temporary stabilization.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 the benefits when deciding whether to remove the implant.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 ven 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.Limited information regarding the event was made available to stryker.Multiple attempts were made to obtain additional information, but no response was received.A root cause cannot be established.If additional information is received or the device is returned for evaluation, the investigation will be reopened and updated.
Event or Problem Description
A physician reported that a patient underwent revision surgery to address a fractured four-level constrained pyrenees plate.

• Brand Name: CONSTRAINED PLATE, 4 LEVEL; SIZE 85 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: 13361709
• Report Number: 3004774118-2022-00029
• Device Sequence Number: 1778455
• Product Code: KWQ
• UDI-Device Identifier: 10888857031401
• UDI-Public: 10888857031401
• 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: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/10/2022

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: 208-44F85
• Device Catalogue Number: 208-44F85
• Device Lot Number: DLTM
• 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: 01/13/2022
• Supplement Date Received by Manufacturer: 04/12/2022
• Initial Report FDA Received Date: 01/26/2022
• Supplement Report FDA Received Date: 05/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/17/2017
• 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: 68 YR
• Patient Sex: Male