MAUDE Adverse Event Report: K2M, INC. POLYAXIAL SCREW; SIZE Ø6.5X40 MM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number	801-06540
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/08/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that approximately two-months post-operatively the mesa screws at right/left l2 and left l3 migrated.All the rods and screws were removed and replaced and the construct was extended.This report captures the screw at right l2.
Additional Manufacturer Narrative
Visual, dimensional, material and functional analysis could not be performed as the device was not returned.Device history records were reviewed for the lot numbers provided, and no relevant manufacturing issues were identified.A review of complaint history associated with the subject catalog number was performed and no adverse trends were observed.It was reported that an initial surgery was performed on (b)(6) 2021 and 3 mesa screws (at right/left l2 and left l3) migrated 1 month post-operatively.The event resulted in a revision surgery.The construct was extended from l2-s2 to t9-s2 on 08feb2022.All rods were removed and backed-out screws were replaced.Per additional correspondence, post-op activity level of the patient is unknown, patient did not experience an external trauma/ fall after initial surgery and bone quality of the patient was reported to be normal.It is unknown how the screw holes were created during the initial surgery.Surgery notes were not provided.Devices was scrapped by customer so an evaluation could not be performed.Since the device was not returned, an exact cause of the reported event could not be determined.Potential causes include: excess post-op activity level of patient, poor fixation construct leaving residual stress, improper screw hole prep during initial surgery, too much residual stress on rod from tightening/rotating/ bending, poor bone quality of patient, etc.
Event or Problem Description
It was reported that approximately two-months post-operatively the mesa screws at right/left l2 and left l3 migrated.All the rods and screws were removed and replaced and the construct was extended.This report captures the screw at right l2.

• Brand Name: POLYAXIAL SCREW; SIZE Ø6.5X40 MM
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): K2M, INC.; 600 hope parkway se; leesburg VA 20175
• Manufacturer (Section G): K2M, INC.; 600 hope parkway se; leesburg VA 20175
• Manufacturer Contact: rita karan ; 2 pearl court; allendale, NJ 07401 ; 2017608000
• MDR Report Key: 13714787
• Report Number: 3004774118-2022-00095
• Device Sequence Number: 6363169
• Product Code: NKB
• UDI-Device Identifier: 10888857136113
• UDI-Public: 10888857136113
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K141873
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/15/2022

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: 801-06540
• Device Catalogue Number: 801-06540
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/10/2022
• Supplement Date Received by Manufacturer: 05/17/2022
• Initial Report FDA Received Date: 03/09/2022
• Supplement Report FDA Received Date: 06/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 76 YR
• Patient Sex: Male