EBI DYNAFIX CORTICAL SCREW * A45-12040

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2006-08-24 for EBI DYNAFIX CORTICAL SCREW * A45-12040 manufactured by Ebi, L.p..

Event Text Entries

[15610616] Screws became stuck in patient's incision.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 2242816-2006-00030
• MDR Report Key: 776371
• Report Source: 08
• Date Received: 2006-08-24
• Date of Report: 2006-08-18
• Date of Event: 2006-07-14
• Date Mfgr Received: 2006-07-26
• Date Added to Maude: 2006-11-06
• Event Key: 0
• Report Source Code: Manufacturer report
• Manufacturer Link: Y
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 0
• Manufacturer Contact: ART KAUFMAN, SR. DIRECTOR
• Manufacturer Street: 100 INTERPACE PARKWAY
• Manufacturer City: PARSIPPANY NJ 07054
• Manufacturer Country: US
• Manufacturer Postal: 07054
• Manufacturer Phone: 9732999300
• Manufacturer G1: *
• Manufacturer Street: *
• Manufacturer City: *
• Manufacturer Country: *
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: EBI DYNAFIX CORTICAL SCREW
• Generic Name: NDF
• Product Code: NDF
• Date Received: 2006-08-24
• Model Number: *
• Catalog Number: A45-12040
• Lot Number: 336101
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Eval'ed by Mfgr: N
• Implant Flag: Y
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 764149
• Manufacturer: EBI, L.P.
• Manufacturer Address: * PARSIPPANY NJ * US
• Baseline Brand Name: EBI XFIX DYNATIX
• Baseline Generic Name: EXTERNAL FIXATOR
• Baseline Model No: A45-12040
• Baseline Catalog No: A45-12040
• Baseline ID: *

Patients

Patient Number	Treatment	Outcome	Date
1	0		2006-08-24