MAUDE Adverse Event Report: K2M, INC. UNKNOWN_K2M_PRODUCT; SPINAL VERTEBRAL BODY REPLACEMENT DEVICE

Catalog Number UNK_SPE

Device Problem Migration or Expulsion of Device (1395)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/01/2020

Event Type  malfunction  

Event Description

Feedback from pmcf for the capri cervical system was received.The replying physician reported a patient implanted with capri at c3 experienced a, "concern for loosening." the patient was reported to have fused, no additional treatments or intervention was performed, and the patient outcome is noted to be "excellent.".

Manufacturer Narrative

The device remains implanted and was therefore not returned for evaluation.Device history records and complaint history could not be reviewed without either the device or a valid lot number.From the ifu: 1.Potential adverse events associated with spinal fusion procedures include, but are not limited to pseudoarthrosis; loosening, bending, cracking or fracture of components, or loss of fixation in the bone with possible neurologic damage, usually attributable to pseudoarthrosis, insufficient bone stock, excessive activity or lifting, or one or more of the factors listed in contraindications, or warnings and precautions; infections possibly requiring removal of devices; palpable components, painful bursa, and/or pressure necrosis; and allergies, and other reactions to device materials which, although infrequent, should be considered, tested for (if applicable), and ruled out preoperatively.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.2.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.3.Metallic 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." limited information regarding the event was made available to stryker and there is not enough information to complete an investigation at this time.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 Description

Feedback from pmcf for the capri cervical system was received.The replying physician reported a patient implanted with capri at c3 experienced a, "concern for loosening." the patient was reported to have fused, no additional treatments or intervention was performed, and the patient outcome is noted to be "excellent.".

• Brand Name: UNKNOWN_K2M_PRODUCT
• Type of Device: SPINAL VERTEBRAL BODY REPLACEMENT DEVICE
• 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: 13509683
• MDR Text Key: 286601778
• Report Number: 3004774118-2022-00057
• Device Sequence Number: 1
• Product Code: MQP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K142016
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK_SPE
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/20/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 54 YR
• Patient Sex: Male