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

Catalog Number	4986855
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/24/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not returned to the manufacturer for evaluation.Therefore, we are unable to determine the definitive cause of the reported event.Although it is unknown if the device led to the event, we are filing this report for notification purposes.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that patient underwent oblique lumbar inter-body fusion surgery (olif) and percutaneous pedicle screw fixation at l2-l4 due to lumbar discopathy.Intra-operatively, while performing olif at l3-l4, cage broke into half and one half remained in the patient.When half of the cage entered the intervertebral space, it was difficult to hammer it for insertion.The sleeve was removed with a sleeve remover, and it was tried to be hammered for insertion again.However, still the cage could not enter and the cage was broken at about half.There was a delay of less than 60 min in overall procedure time as a result of this event.Patient complications were reported as unknown.
Additional Manufacturer Narrative
Product analysis: a visual review of the returned implant identified a portion has been broken off.Microscopic examination of the inserter interface identified a stripped threaded hole and deformation on the top face, and fracture on one side around the inserter tang interface, consistent with significant impact and torsional loading.Microscopic examination of the fracture surface of the broken off portion of the implant identified a fracture with rays emanating away from the area of crack initiation, consistent with brittle overload.The observations are consistent with impaction overload.If information is provided in the future, a supplemental report will be issued.

• Brand Name: CLYDESDALE PTC SPINAL SYSTEM
• Common Device Name: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR
• Manufacturer (Section D): MDT SOFAMOR DANEK PUERTO RICO MFG; barrio marianna rd 909, km0.4; humacao PR 00792
• MDR Report Key: 7521609
• Report Number: 1030489-2018-00715
• Device Sequence Number: 19165870
• Product Code: MAX
• UDI-Device Identifier: 00643169190511
• UDI-Public: 00643169190511
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K133205
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/08/2025
• Device Catalogue Number: 4986855
• Device Lot Number: H5361633
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/03/2018
• Initial Date Received by Manufacturer: 04/24/2018
• Supplement Date Received by Manufacturer: 08/13/2018
• Initial Report FDA Received Date: 05/17/2018
• Supplement Report FDA Received Date: 08/23/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 56 YR