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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LANX, LLC. LANX SPINAL FIXATION SYSTEM SPINOUS PROCESS FUSION PLATE

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LANX, LLC. LANX SPINAL FIXATION SYSTEM SPINOUS PROCESS FUSION PLATE Back to Search Results
Model Number 6201-0008
Event Date 02/23/2011
Event Type  Injury  
Manufacturer Narrative

The two explanted pedicle screws are (model 7715-6545/lot l516305; model 7715-7540/lot lx-2270). Method: the spinous process fusion plate was not returned because it was removed intact with the spinous process. An evaluation could not be performed. Visual examination of the returned pedicle screws did not identify a failure and none was reported. Based on a review of the operative notes the post-operative diagnosis was the same, indicating pseudoarthrosis. The surgeon placed a second interbody cage; the first cage from the index surgery was left in place. Autograft and autologous morsellized bone, and bmp was placed in the disk space. The l5-s1 was re-fixated with bilateral pedicle screws.

 
Event Description

A patient underwent follow-up lumbar fusion surgery. Pre-operative diagnosis indicated pseudoarthrosis l5-s1, bilateral proximal lumbar radiculopathy, and lumbago. The original surgery was performed on (b)(6) 2011 to address discogenic back pain, lumbago, and right lower extremity and radiculopathy. The follow-up surgery required removal of a spinous process fusion plate and removal of unilateral pedicle screws. A laminectomy, foraminotomies, and further decompression of l5-s1 was performed. Operative notes do not indicate a malfunction of the implants and none was alleged.

 
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Brand NameLANX SPINAL FIXATION SYSTEM
Type of DeviceSPINOUS PROCESS FUSION PLATE
Manufacturer (Section F)
LANX, LLC.
broomfield CO
Manufacturer (Section D)
LANX, LLC.
broomfield CO
Manufacturer Contact
gary turner
310 interlocken parkway
suite 120
broomfield , CO 80021
(303) 443 -7500
Device Event Key2064671
MDR Report Key2031045
Event Key1928020
Report Number3004485144-2011-00026
Device Sequence Number1
Product CodeNKB
Report Source Manufacturer
Source Type Distributor
Reporter Occupation NOT APPLICABLE
Type of Report Initial
Report Date 02/24/2011
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/22/2011
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Device MODEL Number6201-0008
Was Device Available For Evaluation? Yes
Date Returned to Manufacturer02/24/2011
Is The Reporter A Health Professional? No
Was The Report Sent To Manufacturer? No
Date Manufacturer Received02/24/2011
Was Device Evaluated By Manufacturer? Yes
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Is the Device an Implant? No
Is this an Explanted Device?
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 03/22/2011 Patient Sequence Number: 1
Treatment
PEEK INTERBODY SPACER
ALLOGRAFT
AUTOGRAFT
BMP
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