MAUDE Adverse Event Report: CLARIANCE SAS ERISMA-LP MIS; 6.5MM X 40MM CANNULATED POLYAXIAL SCREW

Model Number 13016540

Device Problem Positioning Failure (1158)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/23/2019

Event Type  malfunction  

Manufacturer Narrative

The screw was returned to the manufacturer, however, the set screw was not returned.As a consequence, no analysis was able to be performed.

Event Description

The set screw would not start and engage the thread of the head of the erisma-lp mis polyaxial screw.There was a delay of 30 minutes associated with removing the screw and replacing it with an alternative pedicle screw.However, no patient harm was reported and the surgery completed without further incident.

Manufacturer Narrative

The screw was returned to the manufacturer, however, the set screw was not returned.As a consequence, no analysis was able to be performed.12/20/2019 - the screw was returned to the manufacturer, however, the set screw was not returned.As a consequence, no analysis was able to be performed.

Event Description

The set screw would not start and engage the thread of the head of the erisma-lp mis polyaxial screw.There was a delay of 30 minutes associated with removing the screw and replacing it with an alternative pedicle screw.However, no patient harm was reported and the surgery completed without further incident.

• Brand Name: ERISMA-LP MIS
• Type of Device: 6.5MM X 40MM CANNULATED POLYAXIAL SCREW
• Manufacturer (Section D): CLARIANCE SAS; 18 rue robespierre; beaurains, 62217 ; FR 62217
• MDR Report Key: 9786270
• MDR Text Key: 200808632
• Report Number: 3009962553-2019-00004
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 03707780615032
• UDI-Public: (01)03707780615032
• Combination Product (y/n): N
• PMA/PMN Number: K162367
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 09/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/26/2022
• Device Model Number: 13016540
• Device Catalogue Number: 13016540
• Device Lot Number: GA17C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/02/2019
• Date Manufacturer Received: 05/06/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 82 YR