LINVATEC HALL SURGIOTOME DRILL * 5058-01

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1999-07-06 for LINVATEC HALL SURGIOTOME DRILL * 5058-01 manufactured by Linvatec Corp..

Event Text Entries

[22168240] During surgical procedure, surgeon stated drill was not moving as fast as it should. After left side retractor was moved to right, the left lower lip skin was torn (approx 2 x 3 cm) with 2 ridges. Surgeon denied drill was hot during procedure. After procedure, surgeon alleged that the bur guard was not tight and caused injury. Pt followed by plastic surgeon.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW1016722
• MDR Report Key: 231727
• Date Received: 1999-07-06
• Date of Report: 1999-07-02
• Date of Event: 1999-06-07
• Date Added to Maude: 1999-07-16
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 0
• Health Professional: 3
• Initial Report to FDA: 0
• Report to FDA: 0
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Sequence Number: 1

• Brand Name: LINVATEC HALL SURGIOTOME DRILL
• Generic Name: DRILL
• Product Code: DZI
• Date Received: 1999-07-06
• Returned To Mfg: 1999-06-08
• Model Number: *
• Catalog Number: 5058-01
• Lot Number: *
• ID Number: *
• Device Availability: R
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 224622
• Manufacturer: LINVATEC CORP.
• Manufacturer Address: 11311 CONCEPT BLVD. LARGO FL 337734908 US

Device Sequence Number: 2

• Brand Name: MED BURR GUARD
• Generic Name: BURR GUARD
• Product Code: HXY
• Date Received: 1999-07-06
• Returned To Mfg: 1999-06-10
• Model Number: *
• Catalog Number: 00137501200
• Lot Number: *
• ID Number: 06/1994
• Device Availability: R
• Device Age: *
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 2
• Device Event Key: 224624
• Manufacturer: LINVATEC CORP.
• Manufacturer Address: 11311 CONCEPT BLVD. LARGO FL 337734908 US

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	1999-07-06