MAUDE Adverse Event Report: MDT PUERTO RICO OPERATIONS CO CLYDESDALE PTC SPINAL SYSTEM; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

Model Number 4986055

Device Problems Break (1069); Difficult to Remove (1528); Material Deformation (2976)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 08/24/2020

Event Type  malfunction  

Manufacturer Narrative

Outcome attributed to adverse event: device fragment left in patient.Report source.Country: (b)(6).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.

Event Description

Information was received from a healthcare provider via manufacturer representative regarding a patient with an indication of lumbar degenerative spondylolisthesis in need of l2-4 olif procedure used in spinal therapy.It was reported that during inserting the cage, the cage became unable to enter deeply at all, when it was attempted to be removed, inserter(cat: js1400801) came off.Inserter was attempted to be attached again, but the screw thread was broken, so it was unable to be attached.Therefore, when remover and the reported slap hammer were tried being used to remove the cage, slap hammer broke.The broken part was also able to be collected, so no fragments of slap hammer was remained.For making the gap between cage and vertebral body end plate, cobb was inserted, but in the midway, the marker at the tip was noted had moved forward in the image view, it was considered that maybe the cage broke.After that, as the cage was unable to be removed, the posterior part of the cage was inserted as it was, and implanted, the operation was completed.The bone sclerosed and the vertebral end plate was also sclerosed.The vertebral body was also wedged.All the broken cages remained in the disc space.There was a delay of less than 60 mins in overall procedure time.There were no patient symptoms reported.There were no further complications reported regarding the event.

• Brand Name: CLYDESDALE PTC SPINAL SYSTEM
• Type of Device: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR
• Manufacturer (Section D): MDT PUERTO RICO OPERATIONS CO; rd 31 km 24 hm 4; juncos PR 00777
• Manufacturer (Section G): MDT PUERTO RICO OPERATIONS CO; rd 31 km 24 hm 4; juncos PR 00777
• Manufacturer Contact: tricha miles ; 1800 pyramid place; memphis, TN 38132 ; 7635140379
• MDR Report Key: 10533411
• MDR Text Key: 207995385
• Report Number: 3004209178-2020-15923
• 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,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 4986055
• Device Catalogue Number: 4986055
• Device Lot Number: H5548725
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/24/2020
• 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
• Patient Outcome(s): Other
• Patient Age: 73 YR
• Patient Weight: 69