MAUDE Adverse Event Report: GRACE MEDICAL; IMPLANT, OSSICULAR PROSTHESIS

Model Number 720-350

Device Problems Device Damaged Prior to Use (2284); Packaging Problem (3007)

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

Event Date 12/12/2015

Event Type  malfunction  

Event Description

Surgery required device implant as part of the left ear reconstruction.Device implant was removed from pyxis and verified that it was the correct implant.Implant was opened from package and passed off onto sterile field.Scrub tech opened package for implant and upon inspection was found to be in pieces and not usable.The device implant was not used.Another implant was obtained from pyxis and implanted.

• Type of Device: IMPLANT, OSSICULAR PROSTHESIS
• Manufacturer (Section D): GRACE MEDICAL; 8500 wolf lake dr., ste. 110; memphis TN 38133
• MDR Report Key: 5326418
• MDR Text Key: 34312195
• Report Number: 5326418
• Device Sequence Number: 1
• Product Code: ETA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/16/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/24/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 12/15/2015
• Device Model Number: 720-350
• Device Lot Number: 30080
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/16/2015
• Event Location: Hospital
• Date Report to Manufacturer: 12/16/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 28 YR
• Patient Weight: 91