MAUDE Adverse Event Report: LDR MÉDICAL TRIAL IMPLANT HOLDER; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number MB917R

Device Problem Unintended Movement (3026)

Patient Problems Nerve Damage (1979); Pain (1994); Paraplegia (2448); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 09/13/2022

Event Type  Injury  

Event Description

The patient has alleged that "upon emerging from surgery [the patient] had 'no movement in his legs.'" additionally, the patient suffered paraplegia.He also claims that the stop on the trial implant holder was removed from the design, posing a risk of permanent paralysis for the consumers and was the cause of the patient's injury.

Manufacturer Narrative

This is the same patient associated with medwatch 3004788213-2022-00082 and 3004788213-2022-00090.Without a product return, no product evaluation is able to be conducted.The lot number is unknown; therefore the device history records are unable to be reviewed.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.

Manufacturer Narrative

H6 additional patient code: (b)(4).Additional information in h6: component, investigation type, findings, and conclusions.Device evaluation: product was not returned, photos were not provided, x-rays were not provided, and surgical notes were not provided.A device evaluation is unable to be performed.Root cause: root cause was unable to be determined.This event could possibly be attributed to not appropriately following the surgical technique guide, having the inserter set incorrectly, or other unknown operational or patient factors.Dhr review: lot number is not known, therefore a dhr review cannot be performed.Device usage: this device is 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

The patient has alleged that "upon emerging from surgery [the patient] had 'no movement in his legs.'" additionally, the patient suffered paraplegia.He also claims that the stop on the trial implant holder was removed from the design, posing a risk of permanent paralysis for the consumers and was the cause of the patient's injury.

• Brand Name: TRIAL IMPLANT HOLDER
• 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: 16792010
• MDR Text Key: 313800904
• Report Number: 3004788213-2023-00033
• Device Sequence Number: 1
• Product Code: LXH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Exemption Number: 5645646
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 02/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: MB917R
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/27/2023
• Initial Date FDA Received: 04/21/2023
• Supplement Dates Manufacturer Received: 03/27/2023
• Supplement Dates FDA Received: 02/09/2024
• 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
• Patient Outcome(s): Hospitalization; Disability
• Patient Age: 51 YR
• Patient Sex: Prefer Not To Disclose
• Patient Ethnicity: Non Hispanic
• Patient Race: White