MAUDE Adverse Event Report: MDT SOFAMOR DANEK PUERTO RICO MFG CAPSTONE CONTROL PTC SPINAL SYSTEM

Catalog Number	5001122
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Pain (1994)
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 had underwent posterior lumbar interbody fusion at l4-l5.On an unknown date, post-op, the patient complained of lower back pain.It was confirmed by the mri image that brightness changed at upper l5 level; and it was suspected that the patient had infection as he had a crp value of 6.8.L4-l5 intervertebral infection was suspected.Hence, the patient underwent a revision surgery, in which the two cages at l4-l5 level were removed; and iliac bone grafting was performed from the anterior side.According to the healthcare professional, it cannot be determined whether the infection was caused by the cages or not.

• Brand Name: CAPSTONE CONTROL PTC SPINAL SYSTEM
• Manufacturer (Section D): MDT SOFAMOR DANEK PUERTO RICO MFG; barrio marianna rd 909, km0.4; humacao PR 00792
• MDR Report Key: 9548440
• Report Number: 1030489-2020-00018
• Device Sequence Number: 2408198
• Product Code: MAX
• UDI-Device Identifier: 00643169679757
• UDI-Public: 00643169679757
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K171107
• 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): 01/03/2020

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 5001122
• Device Lot Number: H5407207
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/06/2019
• Initial Report FDA Received Date: 01/03/2020
• 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: Other
• Patient Age: 57 YR
• Patient Weight: 75