MAUDE Adverse Event Report: LDR MÉDICAL RETRACTOR

Catalog Number	IG007R
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Pain (1994); Numbness (2415)
Date of Event	03/23/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.
Event or Problem Description
It was reported that a retractor could not be locked during surgery.It moved out and away from the disc space, causing a loss of distraction so that firm hammering was needed to install the implant.After the procedure, the patient had pain in their neck and numbness in their fingers, which is disappearing slowly.
Additional Manufacturer Narrative
Corrections in d4: lot number and udi number, d9, and h3.Additional information in h4.Current information is insufficient to permit a valid conclusion about the cause of this event.A follow up report will be sent upon completion of the device evaluation.
Event or Problem Description
It was reported that a retractor could not be locked during surgery.It moved out and away from the disc space, causing a loss of distraction so that firm hammering was needed to install the implant.After the procedure, the patient had pain in their neck and numbness in their fingers, which is disappearing slowly.
Event or Problem Description
It was reported that a retractor could not be locked during surgery.It moved out and away from the disc space, causing a loss of distraction so that firm hammering was needed to install the implant.After the procedure, the patient had pain in their neck and numbness in their fingers, which is disappearing slowly.
Additional Manufacturer Narrative
Additional information in h6: component, investigation type, findings, and conclusions.Device evaluation: visual inspection revealed no apparent issues with the device.Functional testing revealed that the ratcheting mechanism is working correctly and maintaining full engagement with every tooth even under tension.Root cause: root cause was unable to be determined as no product issue could be identified.Dhr review: per dhr review, the part was likely conforming when it left zimvie control.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.

• Brand Name: RETRACTOR
• Common Device Name: RETRACTOR
• 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: 14197241
• Report Number: 3004788213-2022-00029
• Device Sequence Number: 12132561
• Product Code: GAD
• UDI-Device Identifier: 03662663002523
• UDI-Public: (01)03662663002523(10)A16H134-S029
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/14/2022

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
• Operator of Device: Health Professional
• Device Catalogue Number: IG007R
• Device Lot Number: A16H134-S029
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/30/2022
• Supplement Date Received by Manufacturer: 05/19/2022; 07/01/2022
• Initial Report FDA Received Date: 04/25/2022
• Supplement Report FDA Received Date: 06/08/2022; 07/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/07/2016
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male