MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH UNKNOWN VERTEBRAL BODY REPLACEMENT - MESH; SURGICAL MESH

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

Patient Problems Hematoma (1884); Unspecified Infection (1930); Nerve Damage (1979); Pain (1994); Osteolysis (2377); 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 vertebral body replacement - mesh/unknown lot.Part and lot number are unknown; udi number is unknown.Date of event: implant date is between january 2000 and december 2002.Device available for evaluation: 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: ruf m., et al (2012), treatment of vertebral osteomyelitis by radical debridement and stabilization using titanium mesh cages, spine volume 32, number 9, pages e275¿e280 (germany)doi:10.1097/01.Brs.0000261034.83395.7f.This study aims to evaluate retrospectively the efficacy of titanium mesh cages in a consecutive series of patients with active pyogenic or tubercular infection.Between january 2000 and december 2002, a total of 85 patients (56 male and 29 female) with an average age of 62 years (range 25¿86) with severely destructive vertebral osteomyelitis were operated.Three patients had multiple levels of infection.Out of these patients, 70 patients (71 operations) were evaluated.The operative defect was bridged by titanium mesh cages, filled and surrounded with autologous cancellous bone and local antibiotics (gentamicin-loaded collagen sponge).Cages were placed 3 vertebral bodies in 3 cases (harms cage 228; depuy-acromed, inc., raynham, ma).Posterior instrumentation was added in the thoracic and lumbar spine and in cases of extended fusions in the cervical spine (moss-miami 228; depuy-acromed, inc., and biedermann motech).Preoperative, postoperative, and follow-up radiographs were at our disposal in 66 patients.Average follow-up was 41 months (range 24¿61).The following complications were reported as follows: 1 patient died 20 days postoperatively as a result of hepatic failure.8 patients died from causes unrelated to surgery.1 patient died 8 weeks after surgery due to tachyarrhythmia.1 patient died of gastrointestinal bleeding 9 weeks after surgery.Six patients died more than 3 months after surgery (pneumonia [2], liver cirrhosis, trauma, bladder carcinoma, unknown reason).C-reactive protein was 199.4 mg/l (range 16.0¿385.0) after surgery, and 30.3 mg/l (range 0.2¿265.0) on discharge (norm 0¿9 mg/l).At the latest follow-up, 18 patients pain were graded as p2, 2 patients as p3, 2 patients as p4, and 9 patients as p5 after surgery, neurologic status worsened in 1 patient 1 frankel grade.Revision due to wound infection was performed in 2 patients: 1 at the bone harvest site and 1 at the site of posterior exposure.One revision was due to hematoma in 3 cases, a revision was performed with insertion of a new cage and posterior instrumentation, and in 1 case the posterior instrumentation was extended and combined with vertebroplasty.In 3 patients, a nerve root lesion was observed; 2 resolved spontaneously, and 1 required the implantation of a shorter screw.There was 1 case of iliac vein injury that was repaired intraoperatively.One dural tear was sewn and covered intraoperatively.Adjacent segment decompensation occurred in 2 patients; instrumented an extension of the fusion to include the adjacent level was performed 3 and 4 years after the initial surgery.After surgery, neurologic status remained unchanged in 37 patients.Slight settling of the cage (a maximum of 4 mm) was noted in 11 patients.In 4 patients with osteoporotic bone, a dislocation (settling) of the cage occurred.This report is for an unknown titanium mesh cages and moss miami.This report is for one unknown vertebral body replacement - mesh.This is report 5 of 6 for (b)(4).

• Brand Name: UNKNOWN VERTEBRAL BODY REPLACEMENT - MESH
• Type of Device: SURGICAL MESH
• 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: 9530649
• MDR Text Key: 189229754
• Report Number: 1526439-2019-52814
• Device Sequence Number: 1
• Product Code: EZX
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2019
• 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: 12/03/2019
• 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