MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH UNKNOWN SCREW/ROD CONSTRUCT ACCESSORIES; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

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

Patient Problem Embolism/Embolus (4438)

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown screw/rod construct accessories/unknown lot.Part and lot numbers 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.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

The current report is a retrospective analysis of all 137 patients,all female with mean age of 69 years , data , prospectively collected in the swespine registry, for the period between january 02, 2006,and november 22,2020, and for the device(s) identified mountaineer instrumentation.18 patients¿ data who underwent posterior decompression/excision + instrumentation without graft was also prospectively collected in the swespine registry, for the same period wal also operated on with mountaineer instrumentation.Their mean age was 66 years (range 45-82).Females were 7 (39%).General complications-intraoperative complications: 3 dural tear , 2 oesophagus injury.General complications-postoperative complications within index hospitalization: 2 pulmonary embolism, 2 venous thrombosis , 8 patients undergoing reintervention for a complication, 11 reinterventions for a complication.Readmissions 1: 1 adjustment of implant , 1 drain of deep infection , 1 removal of implant , 1 removal of intracorporal implant , 4 other.Readmissions 2: 1 drain of deep infection.1 other.Readmissions 3: 1 removal of implant.Readmission ( for patients with metastatic malignancy): 1 registered case which underwent re-instrumentation.This is for depuy spine mountaineer instrumentation.

• Brand Name: UNKNOWN SCREW/ROD CONSTRUCT ACCESSORIES
• Type of Device: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• 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: 12414987
• MDR Text Key: 269570938
• Report Number: 1526439-2021-01814
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: SW
• 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: 08/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/02/2021
• 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: 08/04/2021
• 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