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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMET SPINE - BROOMFIELD POL TRANS 5.5 TI 7.5X50MM TRANSLATION SCREW

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BIOMET SPINE - BROOMFIELD POL TRANS 5.5 TI 7.5X50MM TRANSLATION SCREW Back to Search Results
Model Number N/A
Device Problem Difficult to Insert (1316)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/12/2016
Event Type  Injury  
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. Report one of two for the same event, reference 3004485144-2016-00070.
 
Event Description
It is reported the screw was inserted 3/4 of the way, to the base of the tulip, when it became jammed and the surgeon was unable to re-establish a solid interface; meaning the screw wasn't retained well by the inserter. The screw was removed and replaced with a new screw.
 
Manufacturer Narrative
The returned screw was examined and found that there is some material displacement on the inside of the screw seat. The complaint is confirmed. There were no indications of manufacturing issues detected which would have contributed to this event. The labeling was reviewed and contains instructions on device usage.
 
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Brand NamePOL TRANS 5.5 TI 7.5X50MM TRANSLATION
Type of DeviceSCREW
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
teresa george
310 interlocken parkway
suite 120
broomfield, CO 80021
3034437500
MDR Report Key5652858
MDR Text Key45116709
Report Number3004485144-2016-00069
Device Sequence Number1
Product Code NKB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
PK123549
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/15/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/13/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue Number14-578550
Device Lot Number2471401
Other Device ID NumberN/A
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/03/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/29/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/20/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage
Removal/Correction NumberN/A

Patient Treatment Data
Date Received: 05/13/2016 Patient Sequence Number: 1
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