MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH UNKNOWN HANDLES; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Device Problem Device-Device Incompatibility (2919)

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

Event Date 11/19/2021

Event Type  malfunction  

Event Description

Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2021 during a posterior spinal fusion procedure, before the surgery, it was confirmed that two screws and two inserter shafts could not be detached.Two screws were attached to each of the two inserter shafts for preparation according to the surgical plan.Since the stylet was not properly assembled, the surgeon tried to remove the screws once.When the surgeon tried to loosen the green knob of inserter shafts, it was too hard to remove the screw.Same for the other insert shaft and screw.The surgery was performed with other company¿s implants and instruments.The surgery was completed successfully without any surgical delay.After the surgery, sales rep confirmed that one of the two screws and inserter shafts replicated the same non-detachable situation.The other was not reproducible.Patient outcome is reported as stable.No further information is available.This report is for one (1) unknown stylet.This is report 5 of 5 for complaint (b)(4).

Manufacturer Narrative

This report is for an unknown stylet/ unknown lot.Part and lot number are unknown.Without the specific part number; the udi number and 510-k 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.

• Brand Name: UNKNOWN HANDLES
• 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): SENTIO (INNOVATIVE SURGICAL SOLUTIONS, LLC); 50461 west pontiac trail; wixom MI 48393
• Manufacturer Contact: kara ditty-bovard ; 325 paramount drive; raynham, MA 02767 ; 6103142063
• MDR Report Key: 13018600
• MDR Text Key: 284465790
• Report Number: 1526439-2021-02573
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2021
• Is this an Adverse Event Report?: No
• 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: 11/18/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: VIPER PRIME CFX XTAB 7X45MM TI; VIPER PRIME CFX XTAB 7X45MM TI; VIPER PRIME INSERTER SHAFT; VIPER PRIME INSERTER SHAFT