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

Catalog Number	3992210
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/22/2019
Type of Reportable Event	Malfunction
Additional 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.
Event or Problem Description
The patient was presented with g1 degenerative spondylolisthesis and underwent posterior lumbar interbody fusion (plif) at l4/5.Intra-op, after the cage insertion on the right of l4/5, the defective cage was hammered with a plastic hammer on the left.After hammered for a while, the posterior border of the cage protruded about 5 mm to the l4 vertebral posterior wall which had spondylolisthesis, so the physician determined to hammer the cage in additionally with a metal hammer.Then, about 5mm separated from the posterior border of the cage, and the broken part of the cage came off together with the gripping part of standard inserter.After that, the remaining part of the cage was removed with instruments new cage of 1mm smaller was inserted.No patient complications were reported as a result of this event.

• Brand Name: CAPSTONE 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: 8623107
• Report Number: 1030489-2019-00559
• Device Sequence Number: 2354659
• Product Code: MAX
• UDI-Device Identifier: 00643169187535
• UDI-Public: 00643169187535
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K172199
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/20/2019

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: 07/26/2025
• Device Catalogue Number: 3992210
• Device Lot Number: H5363691
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/22/2019
• Initial Report FDA Received Date: 05/20/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1