MAUDE Adverse Event Report: BIOMET SPINE - BROOMFIELD POLARIS 5.5 TI SPINAL SYSTEM; POL TRANS 5.5 TI 6.5X45MM TRANSLATION

Model Number N/A

Device Problem Device Inoperable (1663)

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

Event Date 08/11/2016

Event Type  Injury  

Manufacturer Narrative

Without a product return, no product evaluation is able to be conducted.Current information is insufficient to permit a valid conclusion about the cause of this event.If additional information is obtained that adds value to the relevant content of this report and/or a conclusion can be drawn, a follow-up report will be sent.Report one of two for the same event; see also 3004485144-2016-00214.

Event Description

It was reported that during a l3-l5 posterior lumbar interbody fusion (plif) procedure the surgeon was final tightening the last screw on the ipsilateral side when he complained of the plug spinning freely and not torquing.He replaced the plug for a new plug in case it had been damaged but the same was happening.He then removed the other 2 plugs and rod and removed the splayed screw and replaced with the same size and diameter screw.The replaced screw torqued off fine and the counter torque was in the correct alignment.This was not a revision surgery, only revised the splayed screw, it was a primary implantation for the patient.The same rod was used but 2 plugs were used and disposed off on the problem screw.

• Brand Name: POLARIS 5.5 TI SPINAL SYSTEM
• Type of Device: POL TRANS 5.5 TI 6.5X45MM TRANSLATION
• 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: 5932872
• MDR Text Key: 54078989
• Report Number: 3004485144-2016-00213
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: PK123549
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/11/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/07/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 14-578445
• Device Lot Number: UNKNOWN
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/11/2016
• 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: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention