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

Model Number 4922050

Device Problems Crack (1135); Mechanical Jam (2983)

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

Event Date 05/10/2021

Event Type  malfunction  

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.

Event Description

Information was received from healthcare provider (hcp) via a manufacturer representative regarding a patient who was implanted with a cage using olif.Pre-operative diagnosis for this procedure was spinal canal stenosis.It was reported that the reported cage was stuck in the middle of insertion and could not be inserted any more, and it was damaged when trying to remove it. before inserting the cage, a trial with a height of 8 mm was performed, and a cage with a height of 10 mm was inserted at the physician's judgment. after removing the cage, after inserting a 10 mm high trial, a new cage of the same size was opened and could been placed. 3 intervertebral olif was performed.When trying to pull out the cage at l3,4, an event that the cage cracked occurred.  after that, all the instruments for removal and punches were removed, and the cage was placed again. no patient symptoms or complications as a result of this event.

• Brand Name: CLYDESDALE PTC 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: tricha miles ; 1800 pyramid place; memphis, TN 38132 ; 7635140379
• MDR Report Key: 11906749
• MDR Text Key: 264554368
• Report Number: 1030489-2021-00710
• Device Sequence Number: 1
• Product Code: MAX
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K133205
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/31/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/31/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 4922050
• Device Catalogue Number: 4922050
• Device Lot Number: 32HW
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/10/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1