MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH UNKNOWN SCREW/ROD CONSTRUCT ACCESSORIES; ORTHOSIS, SPONDYLOSTHESIS SPINAL FIXATION

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

Patient Problems Wound Dehiscence (1154); Unspecified Infection (1930); Pain (1994); Seroma (2069); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

There are multiple patients all information is provided in the article.This report is for an unknown screw/rod construct accessories/unknown lot.Part and lot number are unknown; udi number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.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.(b)(4).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.(b)(4).

Event Description

This report is being filed after the review of the following journal article: potter bk et al (2005), transforaminal lumbar interbody fusion clinical and radiographic results and complications in 100 consecutive patients, j spinal disord tech, volume 18, number 4, pages 337-346, (usa).The purpose of the present study was to report our experience with a relatively large series of consecutive transforaminal lumbar interbody fusion (tlif) procedures with an intermediate duration of follow-up.The study included 100 patients with 69 men and 31 women with a mean age at surgery of 38 years (range 18-72).All patients had bilateral posterior pedicle screw-rod instrumentation with either an unknown moss-miami (depuy acromed, (b)(4)) titanium implants or a competitor¿s device.Posterolateral fusion bone graft consisted of local bone combined with either posterior iliac crest autograft (30 patients) or corticocancellous allograft (70 patients).Interbody fusion was performed with structural allograft using an unknown depuy spine vertigraft 2 vg2 or a competitor¿s bioabsorbable spacer.Postoperatively, patients were routinely maintained on a morphine-based patient-controlled analgesia regimen for days 1 and 2 and then transitioned to oral medications.All patients were followed clinically for a minimum of 2 years postoperatively, and 82 patients were available to complete the outcome assessment instruments at a mean of 34 months (range 24¿61 months) postoperatively.Complications were reported as follows: 7 patients had radiographic evidence of probable or definite pseudarthrosis.3 patients with symptomatic pseudoarthroses underwent revision fusion during the study period.2 went on to solid fusion with a satisfactory clinical outcome, and 1 developed persistent pseudarthrosis and subsequently underwent a second revision procedure.2 patients with symptomatic pseudarthrosis had moderate residual symptoms but refused a second procedure.2 patients with potential radiographic pseudarthrosis were lost to follow-up but were doing well clinically at the time of their last postoperative follow-up.2 patients had an early postoperative surgical wound infection.1 patient had wound dehiscence.1 patient had draining seroma (culture-negative).1 patient had an early infection at a posterior iliac crest bone graft harvest site.All wound complications resolved following single irrigation and debridement in the operating suite and appropriate antibiotic treatment.3 patients had postoperative ileus requiring nasogastric tube decompression.1 patient pseudomembranous colitis due to clostridium difficile, all of which resolved without sequelae following treatment.7 patients had transient radiculopathy.5 patients had an affected nerve root at l5.1 patient had an affected nerve root at l4 and s1.5 of these cases resolved completely between 1 and 6 weeks postoperatively.1 patient required readmission to the hospital at 3 months postoperatively for treatment of suspected reflex sympathetic dystrophy, which later improved, and 1 patient was returned to the operating room 6 months postoperatively for nerve root decompression for persistent radicular symptoms with an eventual good result.6 patients had a dural tear.2 of which occurred during revision surgery.All dural tears were treated with primary repair followed by 24 hours of flat bed rest.All resolved without sequela.8 patients reported extremely bothersome low back pain and leg pain (sciatica).12 patients reported very bothersome low back pain and leg pain (sciatica).19 patients reported moderately bothersome low back pain and leg pain (sciatica).27 patients reported slightly bothersome low back pain and leg pain (sciatica).A (b)(6)-year-old male demonstrated a moderate amount of incompletely bridging bone (grade b, possible pseudarthrosis) on the lateral radiograph at 25 months post l5-s1 tlif.A (b)(6)-year-old man demonstrated incomplete (grade c) fusion mass development seen anterior to the rod on the left side (patient¿s right), with the right side demonstrating a grade d atrophic pseudarthrosis with complete resorption of bone graft and absent spanning trabeculae on the ferguson view radiograph at 35 months status post l4-l5 tlif.A (b)(6)-year-old female had likely pseudarthrosis (grade c) on the right on the ferguson view radiograph and an anterior (grade b) possible pseudarthrosis on the lateral view at 17 months post l4-l5 tlif surgery.A (b)(6)-year-old male had grade c like pseudarthrosis on the left as shown on the posterolateral radiographs at 17-months post l5-s1 tlif surgery.Depuy spine product: this report is for the moss-miami (depuy acromed, (b)(4)) titanium implants.This report is for one unknown screw/rod construct accessories.This is report 1 of 5 for (b)(4).

• Brand Name: UNKNOWN SCREW/ROD CONSTRUCT ACCESSORIES
• Type of Device: ORTHOSIS, SPONDYLOSTHESIS SPINAL FIXATION
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• Manufacturer (Section G): MEDOS INT SPINE; chemin blanc 38; le locle ; SZ
• Manufacturer Contact: kara ditty-bovard ; chemin-blanc 38; le locle 02400 ; SZ 02400 ; 6103142063
• MDR Report Key: 9536073
• MDR Text Key: 189300441
• Report Number: 1526439-2019-52887
• Device Sequence Number: 1
• Product Code: MNH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/31/2019
• 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: 12/04/2019
• 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