MAUDE Adverse Event Report: BIOMET SPINE - BROOMFIELD FORTIS ALLOGRAFT INTERBODY SPACER

Model Number N/A

Device Problem Misassembled (1398)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

The sales associate reported the implant package was mislabeled.He states a parallel implant was in a lordotic box.This was identified during inspection on (b)(6) 2015 prior to the date the surgery was scheduled (b)(6) 2015.The implant was not used, therefore there is no impact to a patient.

Manufacturer Narrative

Current information is insufficient to permit a valid conclusion about the cause of this event.The evaluation of the returned product is anticipated but not complete.A follow up report will be submitted upon completion of the evaluation.

Manufacturer Narrative

A visual inspection confirmed the part was parallel, but labeled as lordotic.This incident was isolated to one part; the probable root cause is line clearance between switching part numbers of processing a single donor and incorrect identification of the part.(b)(4).

• Brand Name: FORTIS ALLOGRAFT INTERBODY SPACER
• Type of Device: INTERBODY SPACER
• 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: 4816038
• MDR Text Key: 15573568
• Report Number: 3004485144-2015-00015
• Device Sequence Number: 1
• Product Code: HTR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PEXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative,company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/04/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/03/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/04/2017
• Device Model Number: N/A
• Device Catalogue Number: 3302-1208
• Device Lot Number: THB0354960
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/23/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/29/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1