MAUDE Adverse Event Report: K2M, INC. POLYAXIAL SCREW; SIZE 6.5X45 MM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number	801-06545
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Injury (2348)
Date of Event	03/18/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that two mesa polyaxial screws fractured post-operatively.The patient was revised.This report represents the second of the two screws.
Additional Manufacturer Narrative
Functional, dimensional, and material analysis could not be performed as the device was not available.However, x-rays were provided by the rep.Upon review, it was observed that bilateral screws, implanted at the most caudal level of a construct, broke approximately mid-shaft.Device and complaint history records were reviewed and no relevant manufacturing issues or similar complaints were identified.The mesa degenerative surgical technique was reviewed and the following relevant information was identified: 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.Non-union may have contributed to the failure, as the patient did not fuse.However, as no devices were available for evaluation, the root cause could not be determined conclusively.H3 other text : status and location of the device is unknown.
Event or Problem Description
It was reported that two mesa polyaxial screws fractured post-operatively.The patient was revised.This report represents the second of the two screws.

• Brand Name: POLYAXIAL SCREW; SIZE 6.5X45 MM
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): K2M, INC.; 600 hope parkway se; leesburg VA 20175
• MDR Report Key: 9960467
• Report Number: 3004774118-2020-00069
• Device Sequence Number: 2817620
• Product Code: NKB
• UDI-Device Identifier: 10888857136168
• UDI-Public: 10888857136168
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K141873
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/28/2020

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: No Information
• Device Model Number: 801-06545
• Device Catalogue Number: 801-06545
• Device Lot Number: JKEF
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/18/2020
• Supplement Date Received by Manufacturer: 06/30/2020
• Initial Report FDA Received Date: 04/14/2020
• Supplement Report FDA Received Date: 07/28/2020
• 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