MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 6.0MM TI SOFT ROD 50MM; ORTHOSIS,SPONDYLOSTHESIS SPINAL FIXATION

Model Number 498.150

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

Patient Problems Pain (1994); Weakness (2145); Hypoesthesia (2352)

Event Type  Injury  

Manufacturer Narrative

Patient¿s height is reported as (b)(6).Date of explant is unknown.Complainant device is not expected to be returned for manufacturer.Review/investigation.Without a lot number the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.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

It was reported the patient underwent a spinal fusion on (b)(6) 2002 due to spondylolytic spondylolisthesis and lumbosacral neuritis and underwent an anterior and posterior spinal fusion with instrumentation and autogenous bone graft along with a femoral ring allograft and a gill type procedure.Implants included universal spine system (uss); three (3) 45mm side-opening screws, one (1) 50mm side-opening screw, four (4) 11mm nuts, four (4) collar with grooves and two (2) 6.0mm rods.Other implants included; one (1) fra bone graft, size 5, one (1) cervical spine locking plate 34mm, four (4) 4.35mm expansionhead screws 25mm and four (4) 1.8mm locking screws.Patient was improving and hardware was in place in (b)(6) 2003.On (b)(6) 2003, a cat scan was performed on the lumbar spine and degenerative changes were noted.The patient returned to hospital on (b)(6) 2003 and (b)(6) 2003 due to spondylolisthesis, pain, numbness and swelling in both legs and had discogram injections to the lumbar spine.On (b)(6) 2003, the patient injured his lower back at work and returned to the hospital on (b)(6) 2003 for back pain and spondylolisthesis.On (b)(6) 2004, the patient underwent a revision at l5-s1 due to lower back pain and weakness in both legs.Four (4) pedicle screws were removed and an unknown quantity of rods.It was noted that the previous fusion which occurred on (b)(6) 2002 was found to be very poor on the left-hand side.All four (4) screws were tied and the fusion mass appeared to be sound on the right-hand side but was somewhat bitty on the left-hand side.The fusion was reinforced bilaterally but especially on the left-hand side.Previous hardware on left-hand side was redone.Right-hand side was reinforced and bone graft placed into the pedicle screw holes.It is unknown if any other hardware was removed and it is unknown what hardware was implanted.Surgery was uneventful.Patient experienced deep vein thrombosis, pain and swelling on (b)(6) 2004 and had a back incision with drainage.In (b)(6) 2004 the patient fell and x-rays showed no abnormalities.In (b)(6) 2005, had a flare up and nerve scarring.On (b)(6) 2005 patient had lower back pain radiating down right leg and low chronic back pain on (b)(6) 2006.X-rays showed mild scoliosis on (b)(6) 2006.The patient returned to hospital for an overdose/suicide attempt/acute fractured 5th metacarpal on (b)(6) 2007.On (b)(6) 2007, the patient was in a motor vehicle accident and had back pain going down right leg.X-ray showed a solid fusion anterior/posterior l5-s1, degenerative disc changes; narrowing of the disc space l4-5 with mild bulging and spondylolisthesis.In (b)(6) 2008, the patient had a flare up of pain.On (b)(6) 2009, patient experienced pain in the left leg with deep vein thrombosis.In (b)(6) 2009 the patient had a small annular tear at l4-5 with a slight bulging of the disc and had spinal hardware removed at l5-s1.It is unknown what hardware was removed.Concomitant devices reported: mtf biologics fra bone graft - size 5 (part # 000015, lot # unknown, quantity # 1).This complaint is linked with (b)(4) which captures subsequent surgeries.This complaint involves twenty-four (24) devices.This report is for one (1) 6.0mm ti soft rod 50mm.This is report 13 of 24 for complaint (b)(4).

• Brand Name: 6.0MM TI SOFT ROD 50MM
• Type of Device: ORTHOSIS,SPONDYLOSTHESIS SPINAL FIXATION
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): BRANDYWINE; 1303 goshen parkway; west chester PA 19380
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 7072268
• MDR Text Key: 93441061
• Report Number: 2530088-2017-50014
• Device Sequence Number: 1
• Product Code: MNH
• UDI-Device Identifier: 10705034789040
• UDI-Public: (01)10705034789040(10)LOTNUMBERUNKNOWN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K082572
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 498.150
• Device Catalogue Number: 498.150
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/01/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 21 YR
• Patient Weight: 141