SYNTHES, USA *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1999-04-07 for SYNTHES, USA * manufactured by Synthes, Usa.

Event Text Entries

[15710865] Synthes intraoral distraction appliance, which was placed 3/3/1999 and repaired 3/8/1999 was removed on 3/13/1999 and replaced with an extroral distraction device. The original device was apparently defective and became displaced twice.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 218612
• MDR Report Key: 218612
• Date Received: 1999-04-07
• Date of Report: 1999-03-22
• Date of Event: 1999-03-13
• Date Facility Aware: 1999-03-13
• Report Date: 1999-03-22
• Date Reported to Mfgr: 1999-03-23
• Date Added to Maude: 1999-04-15
• 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: 0
• 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 Details

• Brand Name: SYNTHES, USA
• Generic Name: DISTRACTION APPLIANCE
• Product Code: MON
• Date Received: 1999-04-07
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Age: 10 DAY
• Implant Flag: Y
• Date Removed: V
• Device Sequence No: 1
• Device Event Key: 212021
• Manufacturer: SYNTHES, USA
• Manufacturer Address: ATTN: REGULATORY AFFAIRS 1690 RUSSELL RD. PAOLI PA 19301 US
• Baseline Brand Name: SINGLE VECTOR DISTRACTOR BODY/20MM/LEFT
• Baseline Generic Name: MANDIBLE DISTRACTOR
• Baseline Model No: NA
• Baseline Catalog No: 487.963.311
• Baseline ID: NA
• Baseline Device Family: MANDIBLE DISTRACTOR
• Baseline Shelf Life [Months]: NA
• Baseline PMA Flag: N
• Baseline 510K PMN: Y
• Premarket Notification: K962272
• Baseline Preamendment: N
• Baseline Transitional: N
• 510k Exempt: N

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Hospitalization	1999-04-07