MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH UNKNOWN SCREWS; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD

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

Patient Problem Injury (2348)

Event Type  Injury  

Manufacturer Narrative

There were 25 men and 55 women with a mean age of 67.71 years (range, 54-80 years).510k: this report is for an unknown depuy spine 5.5 mm viper cortical fix fenestrated screw system/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.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: feng s, et al.(2019), effect of robot-assisted surgery on lumbar pedicle screw internal fixation in patients with osteoporosis, world neurosurgery, volume 125, page e1057-e1062 (china).The objective of this study was to compare radiologic and clinical outcomes obtained with robot-assisted versus conventional freehand fluoroscopy-assisted pedicle screw insertion in patients with osteoporosis.Between june 2016 and july 2018,80 patients with osteoporosis and lumbar disease who underwent treatment with pedicle screw fixation were included in the study.There were 25 men and 55 women with a mean age of 67.71 years (range, 54-80 years).Patients were randomized 1:1 to undergo fluoroscopy-assisted freehand pedicle screw placement (control group) or robot-assisted pedicle screw placement (experimental group).In the experimental group, 40 patients (12 men and 28 women) with a mean age of 67.55 years (range, 54-78 years) underwent robot-assisted pedicle screw insertion.In the control group, 40 patients (13 men and 27 women) with a mean age of 67.88 years (range, 54-80 years) underwent freehand fluoroscopy-assisted pedicle screw insertion.All patients were implanted with the unknown depuy spine viper cortical fix fenestrated screw system, 5.5 mm (depuy synthes, raynham, massachusetts, usa).A total of 427 pedicle screws were inserted in 80 patients; 202 pedicle screws were inserted in the experimental group, and 225 pedicle screws were inserted in the control group.Complications were reported as follows: (experimental group): 3 screws had a cortical breach of less than 2mm.(control group): 18 screws had a cortical breach of less than 2mm.1 screw had a cortical breach of more than 2mm.7 screws were revised intraoperatively.This report is for an unknown depuy spine 5.5 mm viper cortical fix fenestrated screw system.This is report 1 of 1 for (b)(4).

• Brand Name: UNKNOWN SCREWS
• Type of Device: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD
• 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 ; 325 paramount drive; raynham, MA 02767 ; 6103142063
• MDR Report Key: 9866486
• MDR Text Key: 193296035
• Report Number: 1526439-2020-00750
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 02/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 02/25/2020
• Initial Date FDA Received: 03/23/2020
• 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