MAUDE Adverse Event Report: K2M, INC. SET SCREW; ATR; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number	101-10001
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Injury (2348); No Code Available (3191)
Date of Event	08/08/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Return status of the device/devices is currently unknown.
Event or Problem Description
A physician reported four denali set screws backed-out post-operatively leading to revision surgery.This record captures the second of the four set screws.
Event or Problem Description
A physician reported four denali set screws backed-out post-operatively leading to revision surgery.This record captures the second of the four set screws.
Additional Manufacturer Narrative
Correction to d.3.And g.1.: updated from 'stryker spine- leesburg' to 'k2m, inc.'.Visual inspection could not be performed as the device was not returned.However, x-rays were provided by the rep.Upon review, it was observed that bilateral screws at the caudal end of the construct disengaged from their associated rods.It appeared that one of the set screws was free floating.Dimensional, functional, and material analysis could not be performed as the device was not returned.Device and complaint history records were reviewed, and no relevant manufacturing or similar complaints were identified.Per surgical technique: final tightening.Final tightening of denali implants is achieved utilizing either the anti-torque alignment tube or praying mantis attached to the anti-torque handle.Ensure the sliding mechanism of the anti-torque handle is facing up to lock onto the instrument.Slide the handle over the small diameter of the tube and then push down onto the hex portion of the instrument.To disengage the handle, pull back on the sliding mechanism and lift up.Insert the torque wrench into the top opening of the assembled praying mantis and anti-torque handle before positioning it on the screw.Introduce the torque wrench tip into the set screw, and then slide the assembled handle down to engage the screw.Final torque tightening may now be completed.The torque indicating wrench or assembled torque limiting wrench and torque limiting shaft both achieve 90 in-lbs of torque for final tightening.The torque limiting wrench will "pop" once the necessary torque is achieved.The proper torque level is achieved with the torque indicating wrench when the line and arrow meet.Note: do not exceed the recommended torque or damage to the instrument or implant may result.As the devices were not available for inspection, the root cause could not be determined conclusively.It is possible that the rods were not fully seated.If a set screw is final tightened while the rod is not fully seated in the screw head, it could compromise the integrity of the capture mechanism at that level.Cross threading or under-torquing/over-torquing the set screw may have also contributed to loosening.

• Brand Name: SET SCREW; ATR
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): K2M, INC.; 600 hope parkway se; leesburg VA 20175
• MDR Report Key: 9120801
• Report Number: 3004774118-2019-00099
• Device Sequence Number: 10874484
• Product Code: NKB
• UDI-Device Identifier: 10888857003842
• UDI-Public: 10888857003842
• 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: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/17/2020

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: 101-10001
• Device Catalogue Number: 101-10001
• Device Lot Number: JEWU
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/27/2019
• Supplement Date Received by Manufacturer: 02/28/2020
• Initial Report FDA Received Date: 09/25/2019
• Supplement Report FDA Received Date: 03/17/2020
• 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