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 Problem Unspecified Tissue Injury (4559)

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.Occupation: reporter is a j&j employee.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

This report is being filed after the review of a clinical evaluation report (cer) from a related research activity database (ddra) for evaluating surgical outcomes of depuy synthes spine fenestrated screws (viper and expedium) with or without the use of spinal cement (confidence or vertecem v+cement)in adult spinal deformity (asd) surgery.From all the surgical asd patients included in the essg database ((b)(6) 2020), 500 were treated specifically with depuy synthes spine screws.(410 patients) of them were female and (90 patients) were male.From them, 34 patients (30 females,4 males) age 68.1 (sd 10.6) were treated with fenestrated screws with or without spinal cement (confidence or vertecem v+ cement):28 with spinal cement and 6 without spinal cement.Type of complications in patients with dps fenestrated screws.Medical : 7 urinary tract infection (minor), 1 bacteremia (minor), 1 sepsis (major), 1 renal failure (major), 1 delirium (minor), 1 re-intubation after extubation (major), 1 pleural effusion (minor), 1 reflex sympathetic dystrophy (major), 1 coagulopathy (minor), 2 anemia (minor), 2 electrolyte imbalance (minor).Intraoperative : 1 abnormal bleeding (ml) (>4l) (minor), 4 dural tear (1 major,3 minor), 1 cement leak (minor).Wound problems: 2 wound dehiscence (2 major), 5 superficial wound infection (2 major, 3 minor), 3 deep wound infection (major).Mechanical: 10 pseudarthrosis (9 major,1 minor), 9 proximal junctional kyphosis (6 major ,3 minor), 5 proximal junctional failure (4 major,1 minor), 1 adjacent segment degeneration (major), 1 distal junctional kyphosis (major), 1 loss of correction (major), 1 vertebral fracture (major), 1 pedicle fracture (major), 10 rod breakage (major), 3 screw loosening (major), 2 screws breakage (major), 1 hook dislodgement (major), 2 set screw dislodgement (major).Neurologic: 1 epidural hematoma (major), 5 radiculopathy (4 major,1 minor), 1 pain (minor).This is for depuy spine fenestrated screws (viper and expedium) and spinal cement confidence.A copy of the clinical evaluation form is being submitted with this regulatory report.

• 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: 11761119
• MDR Text Key: 264454646
• Report Number: 1526439-2021-00860
• 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: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/03/2021
• 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: 04/07/2021
• 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