MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH UNKNOWN RODS; ROD, FIXATION, INTRAMEDULLARY

Device Problem Break (1069)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown rod/unknown lot.Part and lot numbers are unknown; udi number is unknown.Without a lot number the device history records review could not be completed.Product was not returned.(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: robertson p, rawlinson h, hadlow a (2004), radiologic stability of titanium mesh cages for anterior spinal reconstruction following thoracolumbar corpectomy, j spinal disord tech, volume 17, pages 44-52, (new zealand).The purpose of this article is to review the radiologic outcomes in a series where titanium mesh cages (tmc) and autograft were used for corpectomy reconstruction and report any complications and contraindications related to the use of these devices.31 patients (21 males, 10 females) who underwent surgery utilizing a tmc for anterior reconstruction were included in the study.Indications included acute fracture in 15 patients, posttraumatic deformity reconstruction in 10 patients, tumor resection requiring reconstruction in 4 patients (1 aneurysmal bone cyst (abc), 1 giant cell tumor (gct), 2 myeloma), and 2 cases with an infection where anterior decompression required reconstruction.28 patients utilized anterior stabilization devices wherein 15 patients were implanted with the unknown depuy spine harms cage (depuy acromed, raynham, ma), 9 patients with the unknown depuy kaneda sr (depuy acromed, raynham, ma) double rod stabilization system, 1 with the unknown depuy spine profile plate (depuy acromed, raynham, ma), and a single construct using an unknown depuy spine moss/miami (depuy acromed, raynham, ma) screws in the adjacent vertebral bodies and a single rod.In three patients, no anterior stabilization device was used, but all of them had subsequent posterior instrumentation wherein 2 patients were implanted with the unknown depuy spine moss/miami posterior implants.Most patients were braced postoperatively for 3 months.The duration of follow-up averaged 16.4 months, with all but two patients having a minimum of 12 months follow-up: the authors did not specify with patients were implanted with the depuy spine device.Thus, complications will be reported as follows: 2 patients had pneumonia.1 patient had retroperitoneal hematoma requiring drainage.1 patient had abdominal wall bulging.1 patient had a dural tear during posterior surgery.1 patient required a chyle leak during drainage.1 patient had significant subsidence of a cage with 4 percent encroachment of the spinal canal at l3 with a nonunion of the reconstruction.(see figure 4).(kaneda sr) 10 patients had asymmetric cage placement on the anteroposterior (ap) radiograph.The cage was displaced to the side of the surgical approach.These cases were associated with an average kyphosis recurrence of 2.4 degrees.1 patient suffered from acute alcohol withdrawal syndrome.1 patient complained of significant thoracic wall pain after bilateral thoracotomies performed to resect a giant cell tumor.1 patient had a posterior rod breakage where rods had been applied during the front and back revision of a failed anterior construct (iliac crest strut graft and plate).1 patient had a cage fracture seen in a 4-year follow-up radiograph taken by chance while this asymptomatic patient attended for assessment of a neck problem.There was no evidence of subsidence, kyphosis, or recurrence of pseudarthrosis in this case.1 patient had cage subsidence of 13 mm associated with asymmetric cage placement in the coronal plane but not with any postoperative loss of kyphosis correction.This report is for the unknown depuy spine harms cage (depuy acromed, raynham, ma), the unknown depuy kaneda sr (depuy acromed, raynham, ma) double rod stabilization system, the unknown depuy spine profile plate (depuy acromed, raynham, ma), unknown depuy spine moss/miami (depuy acromed, raynham, ma) screws and rod.This is report 7 of 7 for (b)(4).

• Brand Name: UNKNOWN RODS
• Type of Device: ROD, FIXATION, INTRAMEDULLARY
• 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: 9516512
• MDR Text Key: 189152207
• Report Number: 1526439-2019-52765
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: NZ
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/24/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/29/2019
• 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