MAUDE Adverse Event Report: K2M, INC. STRAIGHT ROD, DUAL HEX; SIZE 3.5X400 MM, COCR; POSTERIOR CERVICAL SCREW SYSTEM

Model Number	1111-B35400
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Injury (2348)
Date of Event	08/29/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Return status unknown.
Event or Problem Description
A physician reported that an oct system straight rod, dual hex, cocr fractured 9 months post- operatively.Revision surgery was performed.
Event or Problem Description
A physician reported that an oct system straight rod, dual hex, cocr fractured 9 months post-operatively.Revision surgery was performed.
Additional Manufacturer Narrative
Visual, dimensional, material and functional analysis could not be performed as the device was not returned.However, x-rays were provided by the rep.Upon review, it was observed that a rod fractured at the level superior to the screw at l2.It also appears that a competitor net-like implant was placed between levels t11 and l2.Device and complaint history records review could not be performed as a valid lot code was not provided and could not be obtained.Per surgical technique: potential adverse events 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.2.Potential risks also include those associated with any spinal surgery resulting in neurological, cardiovascular, respiratory, gastrointestinal or reproductive compromise, or death.Postoperative 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.4.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.A root cause could not be determined; however, the location of the fracture and surrounding hardware suggests that patient anatomy may have contributed to the failure.It is possible that patient anatomy coupled with lack of supplemental fixation could allow the rod to fracture under dynamic loading.

• Brand Name: STRAIGHT ROD, DUAL HEX; SIZE 3.5X400 MM, COCR
• Common Device Name: POSTERIOR CERVICAL SCREW SYSTEM
• Manufacturer (Section D): K2M, INC.; 600 hope parkway se; leesburg VA 20175
• MDR Report Key: 9533387
• Report Number: 3004774118-2019-00170
• Device Sequence Number: 2341295
• Product Code: NKG
• UDI-Device Identifier: 10888857018082
• UDI-Public: 10888857018082
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K153370
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/18/2020

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: 1111-B35400
• Device Catalogue Number: 1111-B35400
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/06/2019
• Supplement Date Received by Manufacturer: 04/21/2020
• Initial Report FDA Received Date: 12/30/2019
• Supplement Report FDA Received Date: 05/18/2020
• 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