MAUDE Adverse Event Report: K2M, INC. TRANSVERSE CONNECTOR, ADJUSTABLE, MODIFIED; SIZE (L); POSTERIOR CERVICAL SCREW SYSTEM

Catalog Number	1101-73747M
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/10/2026
Type of Reportable Event	Malfunction
Event or Problem Description
A company representative reported that the tulip of an oasys polyaxial screw disengaged post-operatively.Upon review of x-ray imaging provided, it was observed that an oasys connector and an oasys rod also migrated.A revision surgery is not currently scheduled but may be performed.This report captures the connector.
Additional Manufacturer Narrative
Corrected data: b5, d1, d3, d4, g1.Additional data: g4, h4.H6 coding has been updated to reflect completion of the investigation.
Event or Problem Description
A company representative reported that the tulip of an oasys polyaxial screw disengaged post-operatively.Upon review of x-ray imaging provided, it was observed that a denali transverse connector and an oasys rod also migrated.A revision surgery is not currently scheduled but may be performed.This report captures the connector.

• Brand Name: TRANSVERSE CONNECTOR, ADJUSTABLE, MODIFIED; SIZE (L)
• Common Device Name: POSTERIOR CERVICAL 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: catherine devarenne ; 2 pearl court; allendale, NJ 07401 ; 2017608000
• MDR Report Key: 24520241
• Report Number: 0009617544-2026-00029
• Device Sequence Number: 21271960
• Product Code: NKG
• UDI-Device Identifier: 10888857016286
• UDI-Public: (01)10888857016286(11)241001(10)VYCF-004
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K153370
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/01/2026

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 Catalogue Number: 1101-73747M
• Device Lot Number: VYCF-004
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/10/2026
• Supplement Date Received by Manufacturer: 03/19/2026
• Initial Report FDA Received Date: 03/05/2026
• Supplement Report FDA Received Date: 04/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/01/2024
• 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
• Patient Sex: Unknown