MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH UNK - MONO/POLYAXIAL SCREWS : 6.5MMX45MM: VIPER II; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

Device Problem Device Slipped (1584)

Patient Problems Abscess (1690); Physical Asymmetry (4573)

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown mono/ polyaxial screws/ 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

Device report from synthes reports an event in (b)(6) as follows: this report is being filed after the review of the following journal article: wang q.Y., et al (2017) one-stage extreme lateral interbody fusion and percutaneous pedicle screw fixation in lumbar spine tuberculosis, j musculoskelet neuronal interact volume 17(1), pages 450-455 (china).This study aims to evaluate the effectiveness of one-stage debridement and fusion with a cage or bone graft through the extreme lateral interbody (xlif) channel combined with posterior (or lateral) pedicle screw fixation in 22 patients with lumbar spine tuberculosis.Between october 2012 and march 2014, twelve men and ten women 28 to 79 years old, with lumbar spine tuberculosis who underwent xlif and debridement combined with percutaneous or lateral pedicle screw fixation were included in the study.After conventional standard antituberculosis treatment patients underwent debridement and fusion in the intervertebral space and minimally invasive posterior pedicle screws fixation.Four 6.5 mm × 45 mm titanium screws (viper ii, depuy spine) were used to place the four kwires at the objective vertebra.Finally, pedicle-rods were passed through the relevant trajectory of pedicle screws under the viper ii system.The mean follow-up time was 12.4±1.1 months (11 to 15 months).The following complications were reported as follows: internal fixation loosened in one case after the operation which was attributed to drug treatment disobedience and earlier frequent activities.This patient also had a loss of correction at follow-up.This patient was treated by evacuation of the psoas abscess and improvement of the adherence to drug therapy.This report is for an unknown depuy spine four 6.5 mm × 45 mm titanium screws (viper ii).This is report 6 of 6 for (b)(4).

Event Description

This report is for unk - mono/polyaxial screws : 6.5mmx45mm: viper ii.

• Brand Name: UNK - MONO/POLYAXIAL SCREWS : 6.5MMX45MM: VIPER II
• Type of Device: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE
• 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: 12454967
• MDR Text Key: 271321488
• Report Number: 1526439-2021-01940
• 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: Foreign,Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/10/2021
• 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: 03/07/2022
• 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