MAUDE Adverse Event Report: K2M, INC. CONSTRAINED PLATE, 2 LEVEL; SIZE 40 MM; APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Model Number	208-42F42
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Pain (1994); Shaking/Tremors (2515); Convulsion/Seizure (4406); Unspecified Immune System Problem (4435)
Date of Event	01/01/2013
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient kept device following explantation.
Event or Problem Description
A patient reported undergoing revision surgery to explant a fractured pyrenees plate.The plate was implanted in 2013 and the device was noted to be fractured approximately four months after implantation.The patient reports that in 2014 they experienced pain as well as, "19k white blood count, tremors, seizures, and so forth." in 2015 the device was explanted.The patient reports they are left with, "long term damage that will continue progressively.".
Additional Manufacturer Narrative
Corrected data: d4 (catalogue number).The device was not returned for evaluation.Manufacturing records could not be reviewed as the lot number was not provided.Complaint history was reviewed and no adverse trends were identified for this catalogue number.From the pyrenees surgical technique guide: incidence of pseudoarthrosis could allow for continued dynamic motion within the construct, which may contribute to a failure of this nature.According to the surgical technique, 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.Physical activity and load bearing have been implicated in premature loosening, bending or fracture of internal fixation devices in the absence of complete bone healing.From the pyrenees ifu: these systems are contraindicated in the presence of infection, pregnancy, metabolic disorders or calcified tissues, grossly distorted anatomy, inadequate tissue coverage, drug/alcohol abuse, mental illness, general neurological conditions, immunosuppressive disorders, patients with known sensitivity to materials in the device, obesity, patients who are unwilling to restrict activities or follow medical advice, and any condition where the implants interfere with anatomical structures or precludes the benefit of spinal surgery.Biological factors such as smoking, use of nonsteroidal anti-inflammatory agents, the use of anticoagulants, etc.All have a negative effect on body union.Contraindications may be relative or absolute and must be carefully weighed against the patient's entire evaluation.X-ray imaging analysis notes taken on (b)(6) 2013 were provided.Transverse lucency was observed mid-plate, consistent with fracture line of the plate.Minimal lucency was observed surrounding the superior c5 screws, which may have increased due to motion.7-8 mm of distance between the c6 and c7 spinous processes was observed- the distance increases to 9-10mm with flexion and returns to normal with extension.Upon inspection of the provided images, it was observed that the fracture occurred mid-plate, spanning across two screw holes.It could not be confirmed from the x-ray images if fusion was achieved.Pseudoarthrosis, continual motion, and/or loading may have contributed to the failure.From the available information, device relationship to the patient's symptoms can not be established nor can a conclusive root cause be determined.
Event or Problem Description
A patient reported undergoing revision surgery to explant a fractured pyrenees plate.The plate was implanted in 2013 and the device was noted to be fractured approximately four months after implantation.The patient reports that in 2014 they experienced pain as well as, "19k white blood count, tremors, seizures, and so forth." in 2015 the device was explanted.The patient reports they are left with, "long term damage that will continue progressively.".

• Brand Name: CONSTRAINED PLATE, 2 LEVEL; SIZE 40 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: 12529994
• Report Number: 3004774118-2021-00290
• Device Sequence Number: 8869321
• Product Code: KWQ
• UDI-Device Identifier: 10888857030961
• UDI-Public: 10888857030961
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K063544
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2015
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/17/2021

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: 208-42F42
• Device Catalogue Number: 208-42F40
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/29/2021
• Supplement Date Received by Manufacturer: 11/22/2021
• Initial Report FDA Received Date: 09/24/2021
• Supplement Report FDA Received Date: 12/17/2021
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 34 YR
• Patient Sex: Female