MAUDE Adverse Event Report: LDR MÉDICAL ROI-C MONOBLOCK TRIAL 12MMX14MM H7MM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number MC9013R

Device Problem Mechanical Problem (1384)

Patient Problems Hemorrhage/Bleeding (1888); Discomfort (2330); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 06/23/2022

Event Type  Injury  

Manufacturer Narrative

Without a product return, no product evaluation is able to be conducted.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.Reference reports 3004788213-2022-00055 through 3004788213-2022-00057.

Event Description

It was reported that during surgery, the surgeon felt there was a difference between the height of two different roi-c trial footprints, so elected to place a 1mm taller cage.Then immediately post-operatively, the patient felt unwell, had difficulty breathing, and heavy bleeding.The patient was returned to the or where the cage was removed, the area and clot were cleaned out, and a new cage was installed so the patient was out of danger.This is report two of three for this event.

Manufacturer Narrative

H3: information was entered erroneously into this report; there are no changed from the initial report.Device evaluation mc9013r and mc9027r could not be evaluated since they were not returned and the photos provided were inadequate to determine the failure mode.Potential cause root cause was unable to be determined.This event could possibly be attributed to wear through use over time or multiple sterilization cycles for the trials.Dhr review per dhr review, the parts were likely conforming when they left zimvie control.Device use these devices are used for treatment.If additional information is obtained that adds value to the relevant content of this report, a follow-up report will be sent.

Event Description

It was reported that during surgery, the surgeon felt there was a difference between the height of two different roi-c trial footprints, so elected to place a 1mm taller cage.Then immediately post-operatively, the patient felt unwell, had difficulty breathing, and heavy bleeding.The patient was returned to the or where the cage was removed, the area and clot were cleaned out, and a new cage was installed so the patient was out of danger.This is report two of three for this event.

• Brand Name: ROI-C MONOBLOCK TRIAL 12MMX14MM H7MM
• Type of Device: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): LDR MÉDICAL; quartier europe de l¿ouest; 5, rue de berlin; sainte-savine, na 10300 ; FR 10300
• Manufacturer (Section G): LDR MÉDICAL; quartier europe de l¿ouest; 5, rue de berlin; sainte-savine, na 10300 ; FR 10300
• Manufacturer Contact: kim martinez ; 10225 westmoor dr.; na; westminster, CO 80021 ; 3035144809
• MDR Report Key: 15146855
• MDR Text Key: 297053731
• Report Number: 3004788213-2022-00056
• Device Sequence Number: 1
• Product Code: LXH
• UDI-Device Identifier: 03662663043236
• UDI-Public: (01)03662663043236(10)610323801/08
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: EXEMPT
• 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,Followup
• Report Date: 12/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/02/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: MC9013R
• Device Lot Number: 610323801/08
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/01/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/21/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 52 YR
• Patient Sex: Female
• Patient Weight: 60 KG