MAUDE Adverse Event Report: WARSAW ORTHOPEDICS RIALTO SI FUSION SYSTEM; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

Catalog Number	74200001250
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	Pain (1994)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product code: our (sacroiliac joint fixation).Product was not returned to the manufacturer for evaluation.Therefore, we are unable to determine the definitive cause of the reported event.Ct images review result: single ct image provided showed mild loosing around the screw.No fracture is evident.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that the patient underwent surgery on (b)(6) 2018 due to "isg" pain on the left side with pronounced instability.The alleged implant was implanted in this surgery.No complications were experienced during surgery.After initially 2 weeks of strong feelings of tension, the pain improved.Hence, operation for isg stiffening was done at right side with the same implant on (b)(6) 2019.However, from mid-(b)(6), there was a strong increase in pain again; hence, a follow-up was done (b)(6) 2019.Follow-up x-ray dated: (b)(6) 2019 showed a halo around the implants.According to the surgeon, this was due to loosening of the left implants.Hence, on (b)(6) 2019, the implants were explanted and were replaced with products from other manufacturer.The revision surgery went well, without any complications.
Additional Manufacturer Narrative
Product analysis: visual and optical inspection revealed some wear on the first few rows of the inner threads of the bone screw.The outer threads of the screw have not been damaged.Dimensional check confirmed the screw was made to print.Root cause of screw removal could not be undetermined.If information is provided in the future, a supplemental report will be issued.

• Brand Name: RIALTO SI FUSION SYSTEM
• Common Device Name: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR
• Manufacturer (Section D): WARSAW ORTHOPEDICS; 2500 silveus crossing; warsaw IN 46582
• MDR Report Key: 8604720
• Report Number: 1030489-2019-00532
• Device Sequence Number: 16953025
• Product Code: OUR
• UDI-Device Identifier: 00643169571846
• UDI-Public: 00643169571846
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K161210
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/25/2019

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 Expiration Date: 03/23/2025
• Device Catalogue Number: 74200001250
• Device Lot Number: 0547518W
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/09/2019
• Initial Date Received by Manufacturer: 04/14/2019
• Supplement Date Received by Manufacturer: 07/08/2019
• Initial Report FDA Received Date: 05/13/2019
• Supplement Report FDA Received Date: 07/25/2019
• 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: 35 YR
• Patient Weight: 73