MAUDE Adverse Event Report: K2M, INC. POLYAXIAL SCREW; SIZE 5.0X28 MM; POSTERIOR CERVICAL SCREW SYSTEM

Model Number	7601-05028
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	02/21/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Hospital discarded the device.
Event or Problem Description
It was reported that two yukon oct polyaxial screws broke three weeks post-operatively.The patient is reported to have "felt the screws dislodge" while opening a heavy door.Revision has occurred.This report will represent the second of two screws.
Event or Problem Description
It was reported that two yukon oct polyaxial screws broke three weeks post-operatively.The patient is reported to have "felt the screws dislodge" while opening a heavy door.Revision has occurred.This report will represent the second of two screws.
Additional Manufacturer Narrative
Visual, functional, dimensional, and material analysis could not be performed as the device was not available.Complaint history records were reviewed for this lot, and no similar complaints were identified.We were not able to physically inspect the device; however, photos and x-rays were provided by the complainant.Upon review, it was observed that bilateral screws at the caudal end of the construct had fractured immediately distal to the ball feature of the screw shank.As the incident occurred three weeks after the index surgery, the most likely cause of the reported incident was determined to be patient compliance.Post-operative patient activity may have introduced unanticipated loading within the construct, resulting in screw fracture.Per the ifu, postoperative care and the patient's ability and willingness to follow instructions are two of the most important aspects of successful healing.

• Brand Name: POLYAXIAL SCREW; SIZE 5.0X28 MM
• Common Device Name: POSTERIOR CERVICAL SCREW SYSTEM
• Manufacturer (Section D): K2M, INC.; 600 hope parkway se; leesburg VA 20175
• MDR Report Key: 11555928
• Report Number: 3004774118-2021-00081
• Device Sequence Number: 11813219
• Product Code: NKG
• UDI-Device Identifier: 10888857350014
• UDI-Public: 10888857350014
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K171444
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/28/2021

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: 7601-05028
• Device Catalogue Number: 7601-05028
• Device Lot Number: MRVF
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/22/2021
• Supplement Date Received by Manufacturer: 05/31/2021
• Initial Report FDA Received Date: 03/23/2021
• Supplement Report FDA Received Date: 06/28/2021
• 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