MAUDE Adverse Event Report: LDR MÉDICAL ROI-A CAG MED H16MM 30X39MM 10; INTERVERTEBRAL BODY FUSION SYSTEM IMPLANT

Model Number N/A

Device Problem Activation, Positioning or Separation Problem (2906)

Patient Problem No Information (3190)

Event Date 04/03/2017

Event Type  Injury  

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.Current information is insufficient to permit a valid conclusion about the cause of this event.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.Device not returned.

Event Description

Roi-a : damaged cage and plates did not deploy properly.As reported during a roi-a surgery, implant holder stripped peek cage, the implant did not stay on instrument, therefore the plates did not deploy properly.Another implant was opened to complete surgery.Instrumentation set was inspected in field return and found compliant.No other information provided.

• Brand Name: ROI-A CAG MED H16MM 30X39MM 10
• Type of Device: INTERVERTEBRAL BODY FUSION SYSTEM IMPLANT
• Manufacturer (Section D): LDR MÉDICAL; quartier europe de l¿ouest; 5, rue de berlin; sainte-savine 10300 ; FR 10300
• Manufacturer (Section G): LDR MÉDICAL; quartier europe de l¿ouest; 5, rue de berlin; sainte-savine 10300 ; FR 10300
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 7572457
• MDR Text Key: 110170484
• Report Number: 3004788213-2018-00188
• Device Sequence Number: 1
• Product Code: OVD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PN/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/06/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/01/2019
• Device Model Number: N/A
• Device Catalogue Number: IR5336P
• Device Lot Number: 14-019342
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/03/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/30/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 51 YR