BIOPLEX IMPLANT 2002-121406

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06,07 report with the FDA on 2007-10-17 for BIOPLEX IMPLANT 2002-121406 manufactured by Ebi.

Event Text Entries

[15490073] Surgical procedure: c3-7 acdf. The last 4 of bioplex c implants were being placed at c6-7. The implant fractured at each corner during initial, light impacting of the implant into the disc space. Patient outcome: ok. Fractured implant was not used. An additional implant was available and was used.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 2242816-2007-00049
• MDR Report Key: 930654
• Report Source: 05,06,07
• Date Received: 2007-10-17
• Date of Report: 2007-10-04
• Date of Event: 2007-10-03
• Date Mfgr Received: 2007-10-04
• Device Manufacturer Date: 2007-08-01
• Date Added to Maude: 2007-12-13
• 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: 0
• Event Location: 0
• Manufacturer Contact: ART KAUFMAN, SR. DIRECTOR
• Manufacturer Street: 100 INTERPACE PKWY.
• Manufacturer City: PARSIPPANY NJ 07054
• Manufacturer Country: US
• Manufacturer Postal: 07054
• Manufacturer Phone: 9732999300
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: BIOPLEX IMPLANT
• Product Code: JDK
• Date Received: 2007-10-17
• Catalog Number: 2002-121406
• Lot Number: 591050
• Device Expiration Date: 2009-08-01
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Age: NA
• Device Eval'ed by Mfgr: R
• Implant Flag: N
• Date Removed: B
• Device Sequence No: 1
• Device Event Key: 924633
• Manufacturer: EBI
• Manufacturer Address: PARSIPPANY NJ US

Patients

Patient Number	Treatment	Outcome	Date
1	0		2007-10-17