MAUDE Adverse Event Report: OSTEOMED INTER-PHALANGEAL STERILE SURGICAL KIT; INTERPHLEX FLEXIBLE STABILITY RODS

Model Number 360-2240T

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Information (3190)

Event Date 06/17/2014

Event Type  Injury  

Event Description

The surgeon inadvertently implanted the trial of surgical kit 360-2200 instead of the actual implant (360-2240).

• Brand Name: INTER-PHALANGEAL STERILE SURGICAL KIT
• Type of Device: INTERPHLEX FLEXIBLE STABILITY RODS
• Manufacturer (Section D): OSTEOMED; addison TX
• Manufacturer Contact: latoia phillips ; 3885 arapaho rd.; addison, TX 75001 ; 9726774743
• MDR Report Key: 3964868
• MDR Text Key: 16987706
• Report Number: 2027754-2014-00008
• Device Sequence Number: 1
• Product Code: KWH
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K022887
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Unknown
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/16/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 360-2240T
• Device Catalogue Number: 360-2200
• Device Lot Number: 1072754
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/18/2014
• Initial Date FDA Received: 07/17/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 57 YR