MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH VIPER SYSTEM CANNULATED EXTENDED TAB POLY SCREW 5.5 X 6.0 X 50MM; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

Model Number 186760050

Device Problem Use of Device Problem (1670)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

Visual inspection performed at customer quality (cq) showed the x-tab portion of the implant had broken off from the proximal end.No other issues were identified.A device failure was identified.No definitive root cause was able to be determined as the circumstances surrounding the complaint are unknown.During the investigation no unidentified product design/manufacturing issues or discrepancies were observed that may have contributed to the complaint condition.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Device history lot: product code: 186760050, lot number: 171337.The dhr of product code 186760050, lot 171337, was reviewed and no non-conformances were observed during the manufacturing process.The product was released on november 29, 2017.The dhr was electronically reviewed.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

It was reported that on an unknown date, two units of mis cannulated x-tab 6x50mm ti were received and identified that the x-tab on both devices were cut off.There is no patient involvement.Procedure outcome is unknown.This report is for one (1) viper system cannulated extended tab poly screw 5.5 x 6.0 x 50mm.This is report 1 of 2 for (b)(4).

• Brand Name: VIPER SYSTEM CANNULATED EXTENDED TAB POLY SCREW 5.5 X 6.0 X 50MM
• 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: 11627766
• MDR Text Key: 244204993
• Report Number: 1526439-2021-00644
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 10705034129211
• UDI-Public: (01)10705034129211
• 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
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/07/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 186760050
• Device Catalogue Number: 186760050
• Device Lot Number: 171337
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/04/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/16/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/29/2017
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1