MAUDE Adverse Event Report: BIOMET SPINE - BROOMFIELD ACDF PEEK 5DEG 13X16X8MM

Model Number N/A

Device Problems Device Markings/Labelling Problem (2911); Appropriate Term/Code Not Available (3191)

Patient Problems No Patient Involvement (2645); Not Applicable (3189)

Event Type  malfunction  

Manufacturer Narrative

Current information is insufficient to permit a valid conclusion about the cause of this event.A follow up report will be sent upon completion of the investigation.

Event Description

The sales associate reported the receipt of mislabeled product.The package label read item number 8824-4608; however product inside was etched with item number 8824-4607.No surgery was involved.

Manufacturer Narrative

The sales associate confirmed the product was discarded.Inspection of inventory identified all parts match the labeling.The part in the package is identical to the desired part in all aspects except for being 1mm less in height.There is no increased risk to patient health.This error was discovered by the sales associate outside the surgical setting with no patient involvement.The most likely root cause of the event is human error.

• Brand Name: ACDF PEEK 5DEG 13X16X8MM
• Type of Device: ACDF PEEK
• Manufacturer (Section D): BIOMET SPINE - BROOMFIELD; 310 interlocken parkway; suite 120; broomfield CO 80021
• Manufacturer (Section G): BIOMET SPINE - BROOMFIELD; 310 interlocken parkway; suite 120; broomfield CO 80021
• Manufacturer Contact: michelle cole ; 310 interlocken parkway; suite 120; broomfield, CO 80021 ; 3034437500
• MDR Report Key: 5478883
• MDR Text Key: 39881920
• Report Number: 3004485144-2016-00016
• Device Sequence Number: 1
• Product Code: MQP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK103660
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/05/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/03/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 8824-4608
• Device Lot Number: AJ59383
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/23/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/24/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1