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 Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/30/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported via xray that 3 denali set screws loosened post-operatively.Revision surgery was performed where the implants were explanted.This report captures the first of the three set screws.
Event or Problem Description
It was reported via xray that 3 denali set screws loosened post-operatively.Revision surgery was performed where the implants were explanted.This report captures the first of the three set screws.
Additional Manufacturer Narrative
Visual inspection: upon evaluation of the returned denali set screws, three set screws did not show the proper "windshield wiper" witness marks on its inferior surface, indicating that proper capture strength was not achieved.The observed witness marks suggest that the rod was not fully reduced prior to final tightening.Device history records were reviewed and no relevant manufacturing issues were identified as all units met stryker specifications.Complaint history was reviewed and one similar complaint was identified.The construct spanned from l2 to l5, and it was composed of eight denali polyaxial screws, eight denali atr set screws and two rods.Upon evaluation of the returned denali set screws, three set screws did not have the proper "windshield wiper" witness marks on its inferior surface, indicating that proper capture strength was not achieved.The observed witness marks suggest that the rod was not fully reduced prior to final tightening.If a rod is not fully reduced, sub-optimal engagement between the set screw and rod could compromise the integrity of the capture mechanism, resulting in migration.The most likely root cause for the event is user error.

• 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: 12045895
• Report Number: 3004774118-2021-00184
• Device Sequence Number: 19778703
• 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
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/27/2021

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: 101-10001
• Device Catalogue Number: 101-10001
• Device Lot Number: HUJM
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/17/2021
• Initial Date Received by Manufacturer: 05/29/2021
• Supplement Date Received by Manufacturer: 09/28/2021
• Initial Report FDA Received Date: 06/22/2021
• Supplement Report FDA Received Date: 10/27/2021
• 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
• Patient Age: 47 YR
• Patient Weight: 95