MAUDE Adverse Event Report: K2M, INC. POLYAXIAL SCREW; SIZE 8.5X80 MM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number	101-08580
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Injury (2348)
Date of Event	02/07/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that denali polyaxial screw fractured post-operatively.The patient came in for evaluation and images confirmed that a sacroiliac screw fractured.Revision surgery was performed on and the fractured screw was removed and replaced.
Additional Manufacturer Narrative
Visual inspection: the device was inspected, and it was observed that the screw shank was fractured immediately below the fourth thread.Significant abrasions could be observed on the threads near the fracture site.Device and complaint history records were reviewed and no manufacturing issues or similar complaints were identified.The denali degenerative surgical technique was reviewed and the following relevant information was identified: 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.Non-union may have contributed to the failure.It could not be determined if fusion was achieved.Post-operative patient activity may have introduced unanticipated loading within the construct, resulting in fracture.
Event or Problem Description
It was reported that denali polyaxial screw fractured post-operatively.The patient came in for evaluation and images confirmed that a sacroiliac screw fractured.Revision surgery was performed and the fractured screw was removed and replaced.

• Brand Name: POLYAXIAL SCREW; SIZE 8.5X80 MM
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): K2M, INC.; 600 hope parkway se; leesburg VA 20175
• MDR Report Key: 10072443
• Report Number: 3004774118-2020-00088
• Device Sequence Number: 13644848
• Product Code: NKB
• UDI-Device Identifier: 10888857003767
• UDI-Public: 10888857003767
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K141873
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/03/2020

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: 101-08580
• Device Catalogue Number: 101-08580
• Device Lot Number: ARCL
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/07/2020
• Initial Date Received by Manufacturer: 06/21/2019
• Supplement Date Received by Manufacturer: 08/07/2020
• Initial Report FDA Received Date: 05/19/2020
• Supplement Report FDA Received Date: 09/03/2020
• 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