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	Pain (1994); Injury (2348)
Date of Event	06/12/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a denali atr set screw migrated post-operatively.The patient reported to have localized pain.Revision surgery was performed to remove and replace the migrated set screw.
Additional Manufacturer Narrative
H.4: manufacturing date was corrected form '11/20/2017' to '11/28/2017'.Visual inspection: upon review of the x-rays, it was observed that one of the set screws had disengaged from its associated screw and was free-floating.The device was returned and inspected.It was observed that the underside of the set screw exhibited abrasions indicative of rod contact.However, "windshield wiper" wear patterns were not visible.Functional inspection: the set screw was able to mate properly with a sample screw-rod construct.Device and complaint history records were reviewed and no relevant manufacturing issues or similar complaints were identified.It is possible that the rod was not fully engaged by the set screw.Sub-optimal engagement between the set screw and rod could compromise the integrity of the capture mechanism at that level.
Event or Problem Description
It was reported that a denali atr set screw migrated post-operatively.The patient reported to have localized pain.Revision surgery was performed to remove and replace the migrated set screw.

• 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: 10072446
• Report Number: 3004774118-2020-00089
• Device Sequence Number: 2628710
• 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: 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): 08/19/2020

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: 101-10001
• Device Catalogue Number: 101-10001
• Device Lot Number: GOWL
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/01/2020
• Initial Date Received by Manufacturer: 06/19/2019
• Supplement Date Received by Manufacturer: 07/23/2020
• Initial Report FDA Received Date: 05/19/2020
• Supplement Report FDA Received Date: 08/19/2020
• 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