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U.S. Department of Health and Human Services

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

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BIOMET SPINE - BROOMFIELD POLARIS 5.5 TI SPINAL SYSTEM POL TRANS 5.5 TI 6.5X45MM TRANSLATION Back to Search Results
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.
 
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Brand NamePOLARIS 5.5 TI SPINAL SYSTEM
Type of DevicePOL 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 Key5932872
MDR Text Key54078989
Report Number3004485144-2016-00213
Device Sequence Number1
Product Code NKB
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
PK123549
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
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 Received09/07/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue Number14-578445
Device Lot NumberUNKNOWN
Other Device ID NumberN/A
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/11/2016
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 Unkown
Removal/Correction NumberN/A

Patient Treatment Data
Date Received: 09/07/2016 Patient Sequence Number: 1
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