MAUDE Adverse Event Report: K2M, INC. DEFORMITY, UNIPLANAR SCREW; SIZE 5.5X40 MM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number	801-35540M
Medical Device Problem Codes	Use of Device Problem (1670); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/14/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during intra-operative final locking on the left side of the construct, a mesa deformity uniplanar screw would not lock/engage with a mesa straight rail.Subsequently, the complaint screw and rail were replaced and the procedure was completed successfully with an hour and a half surgical delay.This record captures the screw.
Event or Problem Description
It was reported that during intra-operative final locking on the left side of the construct, a mesa deformity uniplanar screw would not lock/engage with a mesa straight rail.Subsequently, the complaint screw and rail were replaced and the procedure was completed successfully with an hour and a half surgical delay.This record captures the screw.
Additional Manufacturer Narrative
Visual inspection: the device was inspected, and it was observed that the rail was bent/twisted in multiple areas.Indentations can also be observed throughout the device.Functional inspection: the returned mesa rail was functionally tested with a sample mesa screw and sample mesa locker, and the sample screw was able to lock onto the reported rail at all points along the length.The rail was also functionally tested with the reported mesa uniplanar screw (pi 2438120), and no issues were observed.Material analysis: review of the dhr showed that the material properties of the device were manufactured per specifications; therefore, a material analysis was not performed.Device and complaint history records were reviewed and no relevant manufacturing issues or similar complaints were identified.As certain maneuvers applied during actual surgery could not be replicated during functional testing, the failure mode and root cause could not be determined.It is possible that the rail may not have been reduced as advised due to the curvature of deformity or issues with reduction instrument, which could have resulted in difficulty during partial / final locking of the mesa screw.

• Brand Name: DEFORMITY, UNIPLANAR SCREW; SIZE 5.5X40 MM
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): K2M, INC.; 600 hope parkway se; leesburg VA 20175
• MDR Report Key: 10397691
• Report Number: 3004774118-2020-00172
• Device Sequence Number: 11483185
• Product Code: NKB
• UDI-Device Identifier: 10888857139879
• UDI-Public: 10888857139879
• Combination Product (Y/N): N
• PMA/510(K) Number: K141873
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/27/2020

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?: No
• Operator of Device: Health Professional
• Device Model Number: 801-35540M
• Device Catalogue Number: 801-35540M
• Device Lot Number: JJMN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/17/2020
• Initial Date Received by Manufacturer: 07/14/2020
• Supplement Date Received by Manufacturer: 09/29/2020
• Initial Report FDA Received Date: 08/12/2020
• Supplement Report FDA Received Date: 10/27/2020
• 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: Other