MAUDE Adverse Event Report: BIOMET SPINE - BROOMFIELD 4.5 DIA X 510MM TI ALLOY STRAIGHT ROD WITH HEX; POLARIS 4.75 TI SPINAL SYSTEM

Model Number N/A

Device Problem Device Markings/Labelling Problem (2911)

Patient Problem No Patient Involvement (2645)

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 device evaluation.Upon receipt of the returned devices, a second lot number was identified that was not reported.Report two of two for the same event, reference 3004485144-2016-00207.

Event Description

The sales associate reported mislabeled product.They received package 14-585151t which is supposed to be a 4.75 rod but inside was a 4.5 rod.

Manufacturer Narrative

The returned device and packaging were examined.The part number on both the device and packaging label were correct and matched.The product description was correct on the device.The product description on the packaging label listed the incorrect diameter.The complaint is confirmed.The affected items within zimmer biomet's control are being relabeled with the correct product description.

• Brand Name: 4.5 DIA X 510MM TI ALLOY STRAIGHT ROD WITH HEX
• Type of Device: POLARIS 4.75 TI SPINAL SYSTEM
• 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: 6016589
• MDR Text Key: 57066493
• Report Number: 3004485144-2016-00277
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK133746
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2016
• 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: 14-585151T
• Device Lot Number: PY22B
• Other Device ID Number: (01)00888480618386(10)PY22B
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/20/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/15/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/11/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Removal/Correction Number: N/A
• Patient Sequence Number: 1