MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH UNK - SCREW/ROD CONSTRUCT ACCESSORIES: VIPER; SCREW, FIXATION, BONE

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191)

Patient Problem Unspecified Tissue Injury (4559)

Event Type  Injury  

Manufacturer Narrative

This report is for an unk - screw/rod construct/unknown lot.Part and lot numbers are unknown; udi number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.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) to compare usage and outcomes recorded in 74 patients (28 males,46 females) for viper / expedium pedicle screws with vertecem+ against all other surgical cases recorded within the (b)(6) registry between 06 february 2013 and 29 august 2018.Final registry report outcome description: general complications-intraoperative: 1 anaesthesiological.1 pulmonary.Surgical complications- intraoperative adverse events 3 dural lesion.General complications- postoperative surgical before discharge 4 cardiovascular.2 pulmonary.1 cerebral.3 kidney / urinary.1 liver / gi.1 thromboembolism.2 other.2 not documented.1 death.Surgical complications- postoperative surgical before discharge: 1 other hematoma.1 radiculopathy.2 motor dysfunction.2 sensory dysfunction.1 bowel / bladder dysfunction.1 wound infection superficial.10 wound infection deep.1 implant failure.2 other.2 not documented.Reoperations : 4 number of reoperations at any level: 2 adjacent segment pathology.2 failure to reach therapeutic goals.1 hardware removal.1 implant failure.1 instability.1 neurocompression.1 sagittal imbalance.1 unknown.-1 number of reoperations at the same level.1 unknown.This is for unknown depuy spine viper / expedium pedicle screws.This report is for one (1) unk - screw/rod construct.This is report 2 of 4 for complaint (b)(4).

• Brand Name: UNK - SCREW/ROD CONSTRUCT ACCESSORIES: VIPER
• Type of Device: SCREW, FIXATION, BONE
• 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 ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 12512644
• MDR Text Key: 272701009
• Report Number: 1526439-2021-02059
• Device Sequence Number: 1
• Product Code: HWC
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2021
• 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: 08/24/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: Unknown
• Patient Sequence Number: 1