MAUDE Adverse Event Report: MSD DEGGENDORF MFG CRESCENT¿ SPINAL SYSTEM; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT,

Model Number X0610004

Device Problem Crack (1135)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/27/2022

Event Type  malfunction  

Event Description

Information was received from healthcare provider via a manufacturer representative regarding a spacer used for spinal surgery.Procedure performed in the event was tlif.1 levels implanted.It was reported that intra-operatively, during insertion while on inserter the implant cracked, and a small portion was removed.Surgeon left remaining portion of the implant in place.The implant was not completely removed from patient.A very small piece of the implant was removed and discarded.Surgeon spent about 30 minutes trying to remove the implant before deciding to leave it in place.There were no patient symptoms or complications as a result of this event.

Manufacturer Narrative

Neither the device nor films of applicable imaging studies were returned to the manufacturer for evaluation.Therefore, we are unable to determine the definitive cause of the reported event.If information is provided in the future, a supplemental report will be issued.

• Brand Name: CRESCENT¿ SPINAL SYSTEM
• Type of Device: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT,
• Manufacturer (Section D): MSD DEGGENDORF MFG; wertstrasse 17; deggendorf 94469 ; GM 94469
• Manufacturer (Section G): MSD DEGGENDORF MFG; wertstrasse 17; deggendorf 94469 ; GM 94469
• Manufacturer Contact: glen belmer ; 1800 pyramid place; memphis, TN 38132 ; 6122713209
• MDR Report Key: 14490095
• MDR Text Key: 292595311
• Report Number: 1030489-2022-00493
• Device Sequence Number: 1
• Product Code: MAX
• UDI-Device Identifier: 00613994880116
• UDI-Public: 00613994880116
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K094025
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/24/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: X0610004
• Device Catalogue Number: X0610004
• Device Lot Number: 98DM
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/27/2022
• Date Device Manufactured: 02/23/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 58 YR
• Patient Sex: Male