MAUDE Adverse Event Report: SYNTHES BETTLACH SYNFIX(TM)-LR 30MM DEPTH/38MM WIDTH/15MM HEIGHT 8DEG-STER; INTERVERTEBAL FUSION DEVICE W/BONE GRAFT, LUMBAR

Catalog Number 08.802.009S

Device Problem Crack (1135)

Patient Problems Incontinence (1928); Muscle Weakness (1967); Pain (1994); Stenosis (2263); Inadequate Pain Relief (2388); Weight Changes (2607)

Event Type  Injury  

Event Description

Patient original injury occurred (b)(6) 2005.On (b)(6) 2008 during an internal medical consultation; patient presented with chronic low back pain with initial back injury in 2005 when carrying a four inch iron pipe with co-worker.A work compensation case was open in (b)(6) 2005.Patient had a thirty pound weight gain over a five/ six month period; more sedentary due to back pain with some urinary incontinence.Patient had poor activity tolerance with occasional loss of bladder control.Patient tried and failed with conservative treatment.Surgeon reported that there was a significant delay in patient treatment, but ultimately after discography, patient was positive at lower three lumbar segments.Patient was found to have discogenic disease at l3-4, l4-5 and l5-s1 and disc herniation to the right at l4-5.Pre-admission from (b)(6) 2008 states original injury on (b)(6) 2006 with back pain and pain mainly into right hip and legs since that time, some left side pain as well.Patient worked until end of (b)(6) 2007 and quit because of the intense pain, denies smoking; (b)(6).On (b)(6) 2008, patient had a total disc arthroplasty at l3-4 using synthes prodisc.Anterior lumbar interbody fusion (alif) at l4-l5 (08.802.013s x 1ea) and l5-s1 (08.802.009s) using synthes anterior instrumentation and synfix cage with competitors bone morphogenic protein allograft.Anterior discectomy performed at l3-4, l4-5 and l5-s1.Operative report states; during an intra-op fluoroscope intractable back and right worse that left leg pain, secondary to severe discogenic disease at l3-4, l4-5 and l5-s1 with potential right disk herniation at l4-5 and worse degenerative changes at the level.Intraoperative findings; disk degeneration at all three levels, worse at l4-5, discolored; collapse of disk space at all levels.Post-operative summery from (b)(6) 2008 states patient had ongoing pain, with intractable back and leg pain secondary to lumbar discogenic disease at l3-4, l4-5, and l5-s1.Following procedure patient¿s intense back pain and right leg pain essentially gone; still some right groin and thigh soreness but hypertrophic adenoid tissue improved.Patient was on various medications that were causing confusion and did not agree with his system.Initially patient did very well and then after six months began to decline with increasing back, hip, leg pain and paresthesias.Patient also developed erectile dysfunction and urinary incontinence.Surgeon did a thin section ct scan on unknown date and noted that patient had cracks and fractures in both peek spacers and failed fusion at l4-l5 and l5-s1.This report is 1 of 1 for complaint (b)(4).

Manufacturer Narrative

The alert date on this complaint was originally (b)(4) 2009 that was carried over from the netreg file (b)(4).New information was obtained from (b)(4) on (b)(4) 2014.Patient was revised on (b)(6) 2009.Patient's admitting diagnosis states: mechanical complication of other internal orthopedic device, implant and graft with refusion of lumbar/lumbosacral, posterior technique.Surgeon explored and decompressed and found that patient had ongoing stenosis with nerve impingement affecting the l4, l5-s1 nerves.Exploration of fusion was performed at l4-4 and l5-s1; with finding consistent with pseudoarthrosis at both levels.Patient also had movement at those levels and facet joint that was fused posteriorly.Discharge summary done on (b)(6) 2009 reports; worsening intractable back and bilateral leg pain secondary to pseudoarthrosis at l4-5 and l5-s1 with previous anterior lumbar interbody fusion at l4-5 and l5-s1 with what appears to be fracture lines through synthetic cages.Severe central and foraminal stenosis at l3-l4, l4-5 and l5-s1 (this was not appreciated on previous myelograms/ct scanning).Also, reported that l4-5 and l5-s1 posterolateral arthrodesis fusion using competitors bone morphogenic protein, local autologous bone allograft.Patient was revised to pedicle screw and rod instrumentation using pangaea system at l4-s1 levels with bone protein.Surgeon also performed a decompressive laminectomy with extensive foraminotomies at l4, l5, and s1 for central and foraminal decompression along with disk exploration.Revision surgery was completed successfully.(b)(4).A review of the device history records was performed and no complaint related issues were found.Investigation could not be completed and no conclusion could be drawn as no device was returned.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: SYNFIX(TM)-LR 30MM DEPTH/38MM WIDTH/15MM HEIGHT 8DEG-STER
• Type of Device: INTERVERTEBAL FUSION DEVICE W/BONE GRAFT, LUMBAR
• Manufacturer (Section D): SYNTHES BETTLACH; muracherstrasse 3; bettlach CH25 44; SZ CH2544
• Manufacturer (Section G): SYNTHES BETTLACH; muracherstrasse 3; bettlach CH25 44; SZ CH2544
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 4131526
• MDR Text Key: 4938734
• Report Number: 9612488-2014-10395
• Device Sequence Number: 1
• Product Code: MAX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK072253
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Company Representative
• Reporter Occupation: Attorney
• Type of Report: Initial
• Report Date: 09/09/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/01/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/01/2018
• Device Catalogue Number: 08.802.009S
• Device Lot Number: 2334652
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/02/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/20/2008
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Weight: 100