MAUDE Adverse Event Report: K2M, INC. POLYAXIAL SCREW; SIZE 4.5X30 MM; POSTERIOR CERVICAL SCREW SYSTEM

Model Number	7601-04530
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Injury (2348)
Date of Event	10/28/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
Physician reported that two yukon oct polyaxial screws, size 04.5x30mm, broke at the shaft post-operatively.Revision surgery will be performed.This report represents the second of two polyaxial screws.
Additional Manufacturer Narrative
Visual inspection: the device was inspected, and it was observed that the screw shank was fractured immediately distal to the proximal ball feature.The fracture face had a high-low cross-section, and abrasions can also be observed on the screw shank threads.The set screw remained properly placed within the screw saddle.Device and complaint history records were reviewed, and one similar complaint was identified.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.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.The root cause could not be determined conclusively.Incidence of pseudoarthrosis could allow for continued dynamic motion within the construct, which may have contributed to the failure.Dynamic motion can compound cantilever forces at the proximal screw shank, resulting in fracture.It could not be determined if fusion was achieved.
Event or Problem Description
Physician reported that two yukon oct polyaxial screws, size 04.5x30mm, broke at the shaft post-operatively.Revision surgery will be performed.This report represents the second of two polyaxial screws.

• Brand Name: POLYAXIAL SCREW; SIZE 4.5X30 MM
• Common Device Name: POSTERIOR CERVICAL SCREW SYSTEM
• Manufacturer (Section D): K2M, INC.; 600 hope parkway se; leesburg VA 20175
• MDR Report Key: 9371084
• Report Number: 3004774118-2019-00151
• Device Sequence Number: 2902347
• Product Code: NKG
• UDI-Device Identifier: 10888857349810
• UDI-Public: 10888857349810
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K171444
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/19/2020

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: 7601-04530
• Device Catalogue Number: 7601-04530
• Device Lot Number: GGTX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/04/2019
• Initial Date Received by Manufacturer: 10/28/2019
• Supplement Date Received by Manufacturer: 01/26/2020
• Initial Report FDA Received Date: 11/25/2019
• Supplement Report FDA Received Date: 02/19/2020
• 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