MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC PIVOX¿ OBLIQUE LATERAL SPINAL SYSTEM; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT,

Model Number	2161001
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	04/12/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Information was received from a healthcare provider via a manufacturer representative regarding a patient with olif therapy.It was reported that the core of the holder fractured during the drive into the fusion cage, leaving its front metal portion in the patient's body, which could not be removed.There were no symptoms reported.There were no further complications reported regarding the event.There are currently no other surgical plans and the patient has not been discharged from the hospital.The size of the product selected by the operator was in line with the patient's vertebral body size and treatment needs.The operator's operation in the percussion process conformed to the guidance requirements in our operation manual.After the product broke in the patient's body, it could not be taken out.Since the fusion cage was implanted in place, if it was taken out hard, it would cause additional harm to the patient, so it could not be remedied.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: PIVOX¿ OBLIQUE LATERAL SPINAL SYSTEM
• Common Device Name: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT,
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK USA, INC; 4340 swinea rd; memphis TN 38118
• Manufacturer (Section G): MEDTRONIC SOFAMOR DANEK USA, INC; 4340 swinea rd; memphis TN 38118
• Manufacturer Contact: glen belmer ; 1800 pyramid place; memphis, TN 38132 ; 6122713209
• MDR Report Key: 14314448
• Report Number: 1030489-2022-00441
• Device Sequence Number: 5026942
• Product Code: MAX
• UDI-Device Identifier: 00643169639607
• UDI-Public: 00643169639607
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K152277
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 2161001
• Device Catalogue Number: 2161001
• Device Lot Number: NM20E018
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/12/2022
• Initial Report FDA Received Date: 05/07/2022
• Date Device Manufactured: 06/06/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Age: 73 YR
• Patient Sex: Male