NTI REFILL KIT - NIGHTTIME 7700

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 1999-11-23 for NTI REFILL KIT - NIGHTTIME 7700 manufactured by Heraeus Kulzer, Inc..

Event Text Entries

[203905] Dr reported that a female pt had swallowed a nightime nti matrix. He indiciated that he had relined the matrix to a snap fit and the pt could not dislodge the matrix with her tongue; however, she awoke during the night and paniced when the matrix was in her throat. She then swallowed the device. She went to the hosp where they could not locate the device by examination with a "scope". The dr was advised by customer svc rep that the dr did not know the name of the pt when he called. The dr indicated that the pt is now suffering from a sore throat and chest. 11-8-99 called at 8:25 a. M. - the dr was not available - he was with a pt and will return call within 5 mins per receptionist. 12:02 p. M. Attempted to contact the dr. : spoke to the dr. - he indicated that the pt is fine although she is still sore where her esophagus was bruised. On the evening of the incident, 2 wks ago, the pt awakened at 4:00 a. M. With the matrix caught in her throat. She was draming and thought a "pill" was stuck in her throat. Her boyfriend called the e. R. Physician who advised to drink water to dislodge the object. The object was dislodged. According to dr. , the airway was never obstructed. The pt consulted dr the next morning, who referred her to a gastroenterologist who indicated that the device should pass. The physician performed a "scope" procedure under anesthetic, but could not locate the matrix. He indicated at that time that it had already passed from her esophagus. He also advised that the matrix will pass naturally. Dr is not aware if it has passed at this time. The pt had been wearing the device for approx 3 wks before this occurred. Dr assured that the matrix had a firm fit and could not be removed by the tongue. Dr has fabricated over 100 nticss and never has a problem; however, is very concerned about the possibility that this could happen again. He has relined some pt's nti's previously as they became looser. He is suggesting that the matrix be made larger to avoid this. He is very concerned about lawsuits. Following this incident, dr fabricated another nti for the same pt. He used the universal matrix and fabricated it for the maxillary. He was advised that this is not indicated and that it is not the appropriate use for the universal.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 1925223-1999-00001
• MDR Report Key: 251918
• Report Source: 05
• Date Received: 1999-11-23
• Date of Report: 1999-11-19
• Date Mfgr Received: 1999-11-05
• Date Added to Maude: 1999-12-02
• 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: 0
• Reporter Occupation: DENTIST
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Manufacturer Contact: CHERYL ZIMMERMAN
• Manufacturer Street: 4315 S. LAFAYETTE BLVD
• Manufacturer City: SOUTH BEND IN 46614
• Manufacturer Country: US
• Manufacturer Postal: 46614
• Manufacturer Phone: 2192910661
• 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: NTI REFILL KIT - NIGHTTIME
• Generic Name: *
• Product Code: LQZ
• Date Received: 1999-11-23
• Model Number: 7700
• Catalog Number: 7700
• Lot Number: UNK
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Eval'ed by Mfgr: R
• Implant Flag: N
• Date Removed: A
• Device Sequence No: 1
• Device Event Key: 243976
• Manufacturer: HERAEUS KULZER, INC.
• Manufacturer Address: 4315 S. LAFAYETTE BLVD. SOUTH BEND IN 46614 US
• Baseline Brand Name: NTI REFILL KIT - NIGHTIME
• Baseline Generic Name: *
• Baseline Model No: 7700
• Baseline Catalog No: 7700
• Baseline ID: *

Patients

Patient Number	Treatment	Outcome	Date
1	0		1999-11-23