MAUDE Adverse Event Report: MDT SOFAMOR DANEK PUERTO RICO MFG PIVOX OBLIQUE LATERAL SPINAL SYSTEM

Catalog Number	2111255
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/25/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product was not 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 underwent a surgery at l4-s1 using plates, screws and cages.Intra-op, while inserting the cage at l5-s1, where the s1 level was already "cysted", the cage broke.The surgeon left the implant in the patient.A revision surgery was planned to be performed on (b)(6) 2019 for removing the alleged implant; however, the implant has not been removed yet.No information is available if the patient has undergone any revision surgery or not.No patient complications were reported due to this event.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
The revision was planned but the patient was not doing well due to his other previous illness and his old age.The patient received dorsal stabilization.Hence, the implant still remains implanted in the patient.
Additional Manufacturer Narrative
X-ray review results: post-op x-rays for l3-l4 and l4-l5 lateral interbody fusion are provided.At l3-l4, the interbody graft appears appropriately positioned, but the plate is halfway off the vertebral bodies.At l4-l5, the interbody graft appears to violate the l5 endplate and exist in the vertebral body.By report, the instrumented levels were l4-l5 and l5-s1.Based on the reported information and the images, it is confusing if it was a wrong level surgery.If information is provided in the future, a supplemental report will be issued.

• Brand Name: PIVOX OBLIQUE LATERAL SPINAL SYSTEM
• Manufacturer (Section D): MDT SOFAMOR DANEK PUERTO RICO MFG; barrio marianna rd 909, km0.4; humacao PR 00792
• MDR Report Key: 9516862
• Report Number: 1030489-2019-01474
• Device Sequence Number: 1699459
• Product Code: MAX
• UDI-Device Identifier: 00643169601475
• UDI-Public: 00643169601475
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K152277
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/02/2020

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: 2111255
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/25/2019
• Supplement Date Received by Manufacturer: 01/21/2020; 03/30/2020
• Initial Report FDA Received Date: 12/24/2019
• Supplement Report FDA Received Date: 02/20/2020; 04/02/2020
• 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
• Patient Age: 83 YR
• Patient Weight: 70