MAUDE Adverse Event Report: K2M, INC. STRAIGHT ROD; SIZE 3.5X120 MM; POSTERIOR CERVICAL SCREW SYSTEM

Model Number	1101-535120
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/22/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device discarded by hospital.
Event or Problem Description
A surgeon reported post-operative rod slippage of two oct straight rods following a traumatic event experienced by the patient.Fusion had begun.Revision surgery was performed where the rods were explanted.This report captures the first of the two rods.
Event or Problem Description
A surgeon reported post-operative rod slippage of two oct straight rods following a traumatic event experienced by the patient.Fusion had begun.Revision surgery was performed where the rods were explanted.This report captures the first of the two rods.
Additional Manufacturer Narrative
Visual, dimensional, functional and material analysis could not be performed as the device was not returned.Device and complaint history records could not be reviewed as a valid lot number was not provided and could not be obtained.However, a review of complaint history associated with the subject catalog number was performed, and no adverse trends were observed.The yukon oct surgical technique was reviewed and the following relevant information was identified: 1.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.Per email correspondence with sales rep, patient is very active, has a normal bone quality and fusion had begun when the event occurred.It is believed the patient was reaching or extending his neck post surgery, under a table and/or sink in the kitchen.Most likely cause of reported event is patient experiencing traumatic event.

• Brand Name: STRAIGHT ROD; SIZE 3.5X120 MM
• Common Device Name: POSTERIOR CERVICAL SCREW SYSTEM
• Manufacturer (Section D): K2M, INC.; 600 hope parkway se; leesburg VA 20175
• MDR Report Key: 11338719
• Report Number: 3004774118-2021-00048
• Device Sequence Number: 4759989
• Product Code: NKG
• UDI-Device Identifier: 10888857015944
• UDI-Public: 10888857015944
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K153370
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/28/2021

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: 1101-535120
• Device Catalogue Number: 1101-535120
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/22/2021
• Supplement Date Received by Manufacturer: 04/30/2021
• Initial Report FDA Received Date: 02/17/2021
• Supplement Report FDA Received Date: 05/28/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention