MAUDE Adverse Event Report: LACEY MANUFACTURING COMPANY LLC BOSTON ENDO-SURGICAL TECHNOLOGIES NIM PEDICLE PROBE - STRAIGHT; NEUROSURGICAL NERVE LOCATOR

Model Number	PK1015
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	09/19/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Approximately 1 cm tip broke off of pedicle probe and was retained in patient's back.Fda safety report id# (b)(4).

• Brand Name: BOSTON ENDO-SURGICAL TECHNOLOGIES NIM PEDICLE PROBE - STRAIGHT
• Common Device Name: NEUROSURGICAL NERVE LOCATOR
• Manufacturer (Section D): LACEY MANUFACTURING COMPANY LLC
• MDR Report Key: 15527706
• Report Number: MW5112364
• Device Sequence Number: 5861657
• Product Code: PDQ
• UDI-Device Identifier: 00853508002362
• UDI-Public: (01)00853508002362(17)240209(10)
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Voluntary
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 09/28/2022

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 Expiration Date: 02/09/2024
• Device Model Number: PK1015
• Device Catalogue Number: 1639
• Device Lot Number: BE4211
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/30/2022
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 42 YR
• Patient Sex: Male
• Patient Weight: 70 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White