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

Catalog Number	4986050
Medical Device Problem Codes	Use of Device Problem (1670); Malposition of Device (2616)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	04/06/2020
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 presented with l1-l3 lumbar canal stenosis; and underwent l1-l3 oblique lumbar interbody fusion (olif) and l1-l3 posterior fixation.Intra-op, the endplate broke while curetting the intervertebral disc.Olif was being performed using the o-arm and navigation system.Under direct vision, the position of the vertebra disc was confirmed under navigation.The olif retractor was placed, and the cobb, shaver, curette, and olif inserter: all instruments were used.Olif was performed at l1-l2, l2-l3.After changing the patient's position, the surgeon checked the image to confirm the level, and it was confirmed that the cage to be placed at l1-l2 was indwelt in the l1 vertebra body (near the lower endplate).No deviation in the navigation was noted, but the intervertebral disc space was originally narrow (about 4 mm) and the endplate may have been broken while curetting the intervertebral disc.In the surgeon's opinion, the event occurred because check on the c-arm during the olif operation was neglected.As a result of this event, interbody bone grafting was done from the posterior side of l1-l2.There was a delay of less than 60 minutes in overall procedure time due to this event.No further complications were reported intra-operatively.No malfunction for the reported product was alleged.At a later date, on (b)(6) 2020, post-op, it was however confirmed that the alignment in the patient was improved, and there was no complication to the patient.

• 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: 10025106
• Report Number: 1030489-2020-00498
• Device Sequence Number: 2986536
• Product Code: MAX
• UDI-Device Identifier: 00643169190726
• UDI-Public: 00643169190726
• 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: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/05/2020

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: 4986050
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/06/2020
• Initial Report FDA Received Date: 05/05/2020
• 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