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

Model Number PK1015

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 09/19/2022

Event Type  malfunction  

Event 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
• Type of Device: NEUROSURGICAL NERVE LOCATOR
• Manufacturer (Section D): LACEY MANUFACTURING COMPANY LLC
• MDR Report Key: 15527706
• MDR Text Key: 301116037
• Report Number: MW5112364
• Device Sequence Number: 1
• Product Code: PDQ
• UDI-Device Identifier: 00853508002362
• UDI-Public: (01)00853508002362(17)240209(10)
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 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
• Device Operator: 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 Manufacturer Received: Not provided
• Initial Date FDA Received: 09/30/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 42 YR
• Patient Sex: Male
• Patient Weight: 70 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White