MAUDE Adverse Event Report: K2M, INC. DEFORMITY, UNIPLANAR SCREW; SIZE Ø7.5X50 MM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number	801-37550M
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Pain (1994)
Date of Event	05/16/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device location unknown.
Event or Problem Description
A patient was revised to address a fractured mesa deformity screw at right-side l5 and a left-side l5 mesa deformity screw which was "loose in the bone." the patient reported experiencing "progressively more pain" approximately two-months post-operatively.This report captured the fractured, right-side screw.
Additional Manufacturer Narrative
H6: coding has been updated to reflect completion of the investigation.
Event or Problem Description
A patient was revised to address a fractured mesa deformity screw at right-side l5 and a left-side l5 mesa deformity screw which was "loose in the bone." the patient reported experiencing "progressively more pain" approximately two-months post-operatively.This report captured the fractured, right-side screw.

• Brand Name: DEFORMITY, UNIPLANAR SCREW; SIZE Ø7.5X50 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: 16464320
• Report Number: 3004774118-2023-00030
• Device Sequence Number: 19456143
• Product Code: NKB
• UDI-Device Identifier: 10888857140707
• UDI-Public: 10888857140707
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K141873
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/07/2023

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: 801-37550M
• Device Catalogue Number: 801-37550M
• Device Lot Number: PMXD
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/17/2023
• Supplement Date Received by Manufacturer: 05/23/2023
• Initial Report FDA Received Date: 03/01/2023
• Supplement Report FDA Received Date: 06/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/28/2021
• 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 Sex: Female
• Patient Weight: 61 KG