MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC UNK - CAGE/SPACERS; INTERVERTEBAL FUSION DEVICE W/BONE GRAFT, LUMBAR

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Injury (2348); Non-union Bone Fracture (2369); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Pma/510k: this report is for an unknown transforaminal posterior lumbar interbody fusion cage/unknown lot.Part and lot number are unknown.Without the specific part number; the udi number and 510-k number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.(b)(4).Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

This report is being filed after the review of the following journal article: mcclellan jw, mulconrey ds, forbes rj, fullmer ns (2006), vertebral bone resorption after transforaminal lumbar interbody fusion with bone morphogenetic protein (rhbmp-2), j spinal disord tech, volume 19, pages 483-486, (usa).This study was designed as a retrospective radiographic evaluation to highlight previously unreported results in transforaminal lumbar interbody fusion surgery associated with bone morphogenetic protein (rhbmp-2).Between december 2002 and february 2004, 26 patients who underwent a transforaminal lumbar interbody fusion with bone morphogenetic protein were included in the study.A total of 32 lumbar levels were reviewed.There were 14 males and 12 females with an average age of 46.0 years (range, 16-73 years).All patients received a competitor¿s bone graft (infuse).Interbody implants included allograft dowels or interbody cages augmented with autograft or allograft bone.5 levels were implanted with an unknown synthes transforaminal posterior lumbar interbody fusion while the rest of the levels were implanted with competitors¿ devices.In addition to the interbody implant, procedures incorporated local autograft bone in the interbody space.At each level, care was taken to maintain all bone graft and rhbmp-2 within the disc space.All tlif procedures were instrumented posteriorly with an unknown pedicle screw and rod construct bilaterally.All patients followed similar postoperative pain management and therapy protocol.No anti-inflammatory medications were prescribed at any time in the postoperative period.Therapy included early ambulation and excluded excessive trunk bending or twisting.Computed tomography evaluation of the lumbar spine was obtained at an average of 4.4 months postoperatively (range, 3-7 months).The authors did not specify which patients who experienced complications were implanted with a synthes device.Thus, complications will be reported as follows: 13 levels had no evidence of progression toward fusion (absence of bridging trabecular bone in the interbody space or between facet articulations) as demonstrated on computed tomography scan.12 of these levels were noted to contain bone resorbtion in the vertebral bodies.A total of 22 levels had bone resorption defects.11 levels had mild osteolytic defects.4 of these levels were associated with the absence of bridging bone between facet articulations or vertebral endplates.4 levels had moderate osteolytic defects.3 of these levels were associated with the absence of bridging bone between facet articulations or vertebral endplates.7 levels had severe osteolytic defects.5 of these levels were associated with graft subsidence and loss of endplate integrity.This report is for the unknown synthes transforaminal posterior lumbar interbody fusion cage.It captures the following events: no evidence of progression toward fusion, mild, moderate, and severe osteolytic defects, absence of bridging bone between facet articulations or vertebral endplates, bone resorbtion in the vertebral bodies.A copy of the literature article is being submitted with this medwatch.This is report 1 of 2 for (b)(4).

• Brand Name: UNK - CAGE/SPACERS
• Type of Device: INTERVERTEBAL FUSION DEVICE W/BONE GRAFT, LUMBAR
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 10810280
• MDR Text Key: 215330482
• Report Number: 2939274-2020-05028
• Device Sequence Number: 1
• Product Code: MAX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/13/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention