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

Model Number	3001-35540
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/18/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device remains implanted in patient.
Event or Problem Description
It was reported that the inner collet of 2 mesa sm stature spinal system deformity, uniplanar screws; size ø5.5x40 mm broke during reduction.The screws were left in the patient; however, they were not final locked.Surgery was successfully completed with a five minute delay.No adverse consequences or medical intervention were reported.This report captures the second of two screws.
Additional Manufacturer Narrative
Visual, dimensional, material and functional analysis could not be performed as the device remains implanted.Device and complaint history records review could not be performed as a valid lot code was not provided and could not be obtained.It has been determined that the issue may have been related to surgical technique since this type of failure can occur during the locking process.It is possible that the rod was not fully seated into the inner collet prior to partial locking.If the rod is not fully seated prior to partial locking, then the inner collet can be pressed against the rod and may fracture.Ultimately, this potential failure mode was unable to be confirmed since the device remains implanted and no root cause for the issue was able to be determined.
Event or Problem Description
It was reported that the inner collet of 2 mesa sm stature spinal system deformity, uniplanar screws; size ø5.5x40 mm broke during reduction.The screws were left in the patient; however, they were not final locked.Surgery was successfully completed with a five minute delay.No adverse consequences or medical intervention were reported.This report captures the second of two screws.

• 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: 10155627
• Report Number: 3004774118-2020-00115
• Device Sequence Number: 16669496
• Product Code: NKB
• UDI-Device Identifier: 10888857049888
• UDI-Public: 10888857049888
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K141873
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 3001-35540
• Device Catalogue Number: 3001-35540
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/18/2020
• Supplement Date Received by Manufacturer: 07/31/2020
• Initial Report FDA Received Date: 06/15/2020
• Supplement Report FDA Received Date: 08/28/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1