MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH UNK - CONSTRUCTS: VIPER; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

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

Patient Problem Non-union Bone Fracture (2369)

Event Date 04/13/2011

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

This report is being filed after the review of the following journal article: anderson, d.G.Et al (2011), anterior interbody arthrodesis with percutaneous posterior pedicle fixation for degenerative conditions of the lumbar spine, european spine journal, vol.20 (xx), pages 1323¿1330 (usa).The aim of this retrospective study from a prospectively maintained database is to evaluate a cohort of patients following alif combined with posterior percutaneous pedicle screw fixation.Between 2004 to 2008, a total of 50 patients (26 male and 24 female) with a mean age of 48.2 years (age range of 32¿84), who underwent alif with posterior percutaneous pedicle screw fixation, were included in the study.24 patients underwent single-level fusion and 26 patients had a two-level fusion for a total of 76 levels fused.Surgery was performed using viper system (depuy spine, raynham, ma, usa) together with competitor devices.Patients were evaluated postoperatively at the 2-week, 3-, 6- and 12-month time points for a clinical examination and to obtain radiographs of the lumbar spines.The mean follow-up period was unknown.The following complications were reported as follows: a mean of 8.2% of the patients' fusion grading was observed as "probably not fused" (defined as graft intact, but a radiolucent line is seen between the graft and an adjacent endplate).1 patient had ileus requiring an ng tube for 2 days.1 patient had scrotal edema.1 patient had tachycardia, transient hypotension with trace pericardial effusion (medically managed).1 patient had urinary retention.2 patients had urinary tract infection.This report is for an unknown depuy spine viper constructs.

Manufacturer Narrative

Product complaint # (b)(4) depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.H10 additional narrative: d1: updated impacted product.H3, h6: the investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.Based on the information available, it has been determined that no corrective and 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.

• Brand Name: UNK - CONSTRUCTS: VIPER
• 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: 12454494
• MDR Text Key: 271253806
• Report Number: 1526439-2021-01935
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Health Professional,Company Representative
• 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?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/02/2021
• 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