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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMET SPINE LATERAL INTERVERTEBRAL BODY/VBR FUSION SYSTEM; LATERAL ARTICULATING ARM

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BIOMET SPINE LATERAL INTERVERTEBRAL BODY/VBR FUSION SYSTEM; LATERAL ARTICULATING ARM Back to Search Results
Model Number 8734-0020
Device Problem Device Inoperable (1663)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/06/2015
Event Type  malfunction  
Event Description
During surgery, the arm joint in the articulating arm was unable to be tightened.Even though the incision was made and the retractor was inserted into the patient, the surgery was cancelled and the wound was closed without completing the procedure.
 
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Brand Name
LATERAL INTERVERTEBRAL BODY/VBR FUSION SYSTEM
Type of Device
LATERAL ARTICULATING ARM
Manufacturer (Section D)
BIOMET SPINE
broomfield CO
Manufacturer Contact
stephen morey
310 interlocken parkway
suite 120
broomfield, CO 80021
3034437500
MDR Report Key4564319
MDR Text Key18922160
Report Number3004485144-2015-00003
Device Sequence Number1
Product Code NKB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Distributor
Reporter Occupation Not Applicable
Type of Report Initial
Report Date 02/23/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model Number8734-0020
Device Lot NumberL555566
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer02/10/2015
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 02/06/2015
Initial Date FDA Received02/27/2015
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/01/2012
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Patient Outcome(s) Other;
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