MAUDE Adverse Event Report: ASPEN SURGICAL PRODUCTS, INC. BARD-PARKER 15 BLADE; BLADE, SCALPEL

Catalog Number 371115

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 04/05/2022

Event Type  malfunction  

Event Description

Scalpel blade tip, approx 2-3 mm broke deep in vertebral body during l4-l5 diskectomy.Scalpel blade used to scrape bony defects during decompression procedure.Tip appears to the right-side of the l4-l5 disc space.Fda safety report id # (b)(4).

• Brand Name: BARD-PARKER 15 BLADE
• Type of Device: BLADE, SCALPEL
• Manufacturer (Section D): ASPEN SURGICAL PRODUCTS, INC.; caledonia MI 49316
• MDR Report Key: 14075146
• MDR Text Key: 289088483
• Report Number: MW5108877
• Device Sequence Number: 1
• Product Code: GES
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 04/06/2022

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 Catalogue Number: 371115
• Device Lot Number: 0256657
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/08/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 53 YR
• Patient Sex: Female
• Patient Weight: 63 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White