SYNTHES * 447.00 X 1 (10 HOLE/2 PLATES)

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2004-11-17 for SYNTHES * 447.00 X 1 (10 HOLE/2 PLATES) manufactured by Synthes Usa.

Event Text Entries

[342637] Pt underwent craniotomy for a significant left parietal and parasagittal menigioma in 1993. Plates and screws from suspect medical device were implanted during the surgery in 1993. Over time one of the titanium plates eroded through the scalp and perforated the skin over the ears. In 2004 surgery was performed to reopen craniotomy, debride and remove old titanium plates and screws, place new titanium mesh over the cranial defect in the sagittal area, and revise the craniotomy scar.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 555528
• MDR Report Key: 555528
• Date Received: 2004-11-17
• Date of Report: 2004-10-14
• Date of Event: 2004-09-01
• Date Facility Aware: 2004-10-07
• Report Date: 2004-10-14
• Date Reported to Mfgr: 2004-10-14
• Date Added to Maude: 2004-11-19
• Event Key: 0
• Report Source Code: User Facility report
• Manufacturer Link: N
• 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: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Sequence Number: 1

• Brand Name: SYNTHES
• Generic Name: MAXILLOFACIAL CRANIOTOMY SET
• Product Code: KIT
• Date Received: 2004-11-17
• Model Number: *
• Catalog Number: 447.00 X 1 (10 HOLE/2 PLATES)
• Lot Number: UNK
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Age: 11 YR
• Implant Flag: Y
• Date Removed: V
• Device Sequence No: 1
• Device Event Key: 545171
• Manufacturer: SYNTHES USA
• Manufacturer Address: PO BOX 1766 1690 RUSSELL RD PAOLI PA 19301 US

Device Sequence Number: 2

• Brand Name: SYNTHES
• Generic Name: MAXILLOFACIAL CRANIOTOMY SET
• Product Code: KTT
• Date Received: 2004-11-17
• Model Number: *
• Catalog Number: 443.45 X 4 (5 HOLE)
• Lot Number: UNK
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Age: 11 YR
• Implant Flag: Y
• Date Removed: V
• Device Sequence No: 2
• Device Event Key: 545171
• Manufacturer: SYNTHES USA
• Manufacturer Address: PO BOX 1766 1690 RUSSELL ROAD PAOLI PA 19301 US

Device Sequence Number: 3

• Brand Name: SYNTHES
• Generic Name: MAXILLOFACIAL CRANIOTOMY SET
• Product Code: KTT
• Date Received: 2004-11-17
• Model Number: *
• Catalog Number: 443.44 X 1 (4 HOLE)
• Lot Number: UNK
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Age: 11 YR
• Implant Flag: Y
• Date Removed: V
• Device Sequence No: 3
• Device Event Key: 545171
• Manufacturer: SYNTHES USA
• Manufacturer Address: PO BOX 1766 1690 RUSSELL ROAD PAOLI PA 19301 US

Patients

Patient Number	Treatment	Outcome	Date
1	21	1. Hospitalization; 2. Required No Informationntervention	2004-11-17