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

Catalog Number	4986845
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	Injury (2348)
Date of Event	05/28/2019
Type of Reportable Event	Serious Injury
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
It was reported that the patient was pre-operatively diagnosed with lumbar kyphoscoliosis; and underwent lumbar anterior fixation and oblique lumbar interbody fusion at l1-l5.The cages were being placed from the lower vertebrae moving towards upper vertebrae.Intra-op, when inserting the last cage at l1-l2, the anterior longitudinal ligament (all) got injured.While adjusting the position of the cage, when the physician checked the sagittal image, the cage was found inserted at the anterior side of the vertebral body.The cage was removed temporarily, and the 'all' was found almost cut.The physician was suggested to place a bigger cage behind and make it stable as a recovery; however, cage placement was given up because it was frightening for the surgeon as he thought that the cage would come out from the anterior side.With the physician¿s judgement, the l1-l2 vertebra was sutured using a metal wire and ultra blade so as not to open the anterior side, and the operation was completed without inserting the cage.Operation time was extended for about 90 minutes.

• 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: 8740838
• Report Number: 1030489-2019-00671
• Device Sequence Number: 2371842
• Product Code: MAX
• UDI-Device Identifier: 00643169190535
• UDI-Public: 00643169190535
• 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: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 4986845
• Device Lot Number: H5493903
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/28/2019
• Initial Report FDA Received Date: 06/27/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 79 YR