MAUDE Adverse Event Report: LDR MÉDICAL PEDICLE SCREW 6 MM L 40 MM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number N/A

Device Problem Fitting Problem (2183)

Patient Problem No Code Available (3191)

Event Date 04/10/2018

Event Type  Injury  

Manufacturer Narrative

Product was not returned to manufacturer.No examination could be performed.The review of the traceability and device history records did not reveal any non-conformances to specifications or deviations in procedures that might have contributed to the reported event additional information were requested to reporter.Conclusion is not yet available.Investigation still in progress.

Event Description

Easyspine : screw diameter not fit.According to the reporter : "screw diameter 6 mm too narrow therefore change to 7 mm.No consequences for the patient because the screws in diameter 7 have been implanted" additional information were requested.Investigation in progress.

Manufacturer Narrative

Without a product return, no product evaluation can be conducted.Review of traceability and review of the device history records did not reveal any non-conformances to specifications or deviations in procedures that might have contributed to the reported event.As reported : screw diameter 6mm too narrow so change to 7mm no consequences for the patient because the screws in diameter 7 have been installed.No other information provided.Regarding information provided, root cause is related to an user error.The investigation found no evidence to indicate a device issue.If additional information is obtained that adds value to the relevant content of this report and/or a conclusion can be drawn, a follow-up report will be sent.

• Brand Name: PEDICLE SCREW 6 MM L 40 MM
• Type of Device: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): LDR MÉDICAL; quartier europe de l¿ouest; 5, rue de berlin; sainte-savine 10300 ; FR 10300
• MDR Report Key: 7486037
• MDR Text Key: 107315613
• Report Number: 3004788213-2018-00138
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• PMA/PMN Number: PN/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 07/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/01/2022
• Device Model Number: N/A
• Device Catalogue Number: ES162T
• Device Lot Number: 702236
• Other Device ID Number: N/A
• Date Manufacturer Received: 04/10/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1