MAUDE Adverse Event Report: K2M, INC. UNKNOWN_K2M_PRODUCT; APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Catalog Number UNK_SPE

Device Problems Fracture (1260); Failure to Osseointegrate (1863)

Patient Problem Injury (2348)

Event Date 03/08/2020

Event Type  Injury  

Manufacturer Narrative

Device remains implanted in patient.

Event Description

It was reported that a pyrenees translational screw fractured post-operatively.The patient failed to fuse and is planned to be revised.

Event Description

It was reported that a pyrenees translational screw, that was implanted on the anterior side of the patient's spine, had fractured post-operatively.A follow-up ct scan revealed the screw was fractured and that the patient had failed to fuse.It was reported that the patient started to experience unspecified symptoms after a fall.The surgeon performed revision surgery by placing additional fixation on the posterior side of the spine.Thus, the fractured screw remains implanted on the anterior side of the patient's spine.

Manufacturer Narrative

Correction to "adverse event and product problem." functional, dimensional, and material analysis could not be performed because the device remains implanted in the patient.However, x-rays were provided and upon review, it was observed that a screw, implanted at the distal end of a 3-level plate, had backed out and was fractured.A review of the device and complaint history records could not be performed as a valid lot code was not provided and could not be obtained.The pyrenees constrained and translational surgical technique was reviewed and the following relevant information was identified: it is the responsibilty of the physician to adequately instruct the patient that 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.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.Periodic x-rays for at least the first year postoperatively are recommended for close comparison with postoperative conditions to detect any evidence of changes in position, nonunion, loosening, and bending or cracking of components.With evidence of these conditions, patients should be closely observed, the possibilities of further deterioration evaluated, and the benefits of reduced activity and/or early revision considered.It is likely that impact from the fall introduced unanticipated loading to the construct, allowing the screw to back out from the plate and fracture.Non-union may have also contributed to the failure.

• Brand Name: UNKNOWN_K2M_PRODUCT
• Type of Device: APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
• Manufacturer (Section D): K2M, INC.; 600 hope parkway se; leesburg VA 20175
• MDR Report Key: 9935437
• MDR Text Key: 186840940
• Report Number: 3004774118-2020-00066
• Device Sequence Number: 1
• Product Code: KWQ
• Combination Product (y/n): N
• PMA/PMN Number: K162664
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 06/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK_SPE
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 52 YR