MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORP COLLATAPE; DENTAL PRODUCTS

Catalog Number 0100

Device Problem Material Integrity Problem (2978)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/21/2020

Event Type  malfunction  

Manufacturer Narrative

Sample was not received for evaluation.Dhr review did not identify any discrepancy during the product¿s manufacturing process which could have contributed and/or be related to the reported condition.The reported lot complied with all specifications and testing requirements.Failure analysis - retain samples from the same lot number were visually inspected; no anomaly was observed in any of the units; packaging was in good condition; sealing area was acceptable; no foreign matter was observed.Five (5) units were evaluated for thickness testing.Results: all tested units were within thickness specifications (0.01 to 0.03 in.).The complaint is considered unconfirmed, no further analysis is possible at the moment; therefore, the root cause is undetermined.

Event Description

A physician noticed during the surgery that the thickness of the colla tape (id 0100) was thinner than usual.No patient injury and the event did not led to surgical delay.

• Brand Name: COLLATAPE
• Type of Device: DENTAL PRODUCTS
• Manufacturer (Section D): INTEGRA LIFESCIENCES CORP; 1000 campus drive; 1000 campus drive; princeton NJ 08536
• Manufacturer (Section G): INTEGRA LIFESCIENCES CORP; 1000 campus drive; princeton NJ 08536
• Manufacturer Contact: vivian nelson ; 1000 campus drive; princeton, NJ 08536 ; 6099362319
• MDR Report Key: 10283278
• MDR Text Key: 206967629
• Report Number: 1121308-2020-00008
• Device Sequence Number: 1
• Product Code: LPG
• Combination Product (y/n): N
• PMA/PMN Number: P840062
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/16/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 0100
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/28/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1