MAUDE Adverse Event Report: WARSAW ORTHOPEDICS PIVOX OBLIQUE LATERAL SPINAL SYSTEM; APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Catalog Number	2140130
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/31/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device 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 oblique lumbar interbody fusion(olif) at s1.Post-operatively, the screw pulled out.The surgeon placed the screw anteriorly into the s1 vertebral body during the olif procedure.Due to poor bone quality, the screw pulled out and was noticed the next day during a posterior procedure for pedicle screw fixation.The screw still remains in service.No patient complications were reported.
Additional Manufacturer Narrative
Image review: post-op x-rays provided for l5-s1 olif with posterior pedicle screw fixation.The anterior plate for the construct is not fixed to s1.The interbody graft appears in good position as well as the pedicle screws.Likely cause is surgical technique.If information is provided in the future, a supplemental report will be issued.

• Brand Name: PIVOX OBLIQUE LATERAL SPINAL SYSTEM
• Common Device Name: APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
• Manufacturer (Section D): WARSAW ORTHOPEDICS; 2500 silveus crossing; warsaw IN 46582
• MDR Report Key: 7062469
• Report Number: 1030489-2017-02394
• Device Sequence Number: 16586748
• Product Code: KWQ
• UDI-Device Identifier: 00643169634763
• UDI-Public: 00643169634763
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K152277
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/25/2018

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 Catalogue Number: 2140130
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/01/2017
• Supplement Date Received by Manufacturer: 01/12/2018
• Initial Report FDA Received Date: 11/28/2017
• Supplement Report FDA Received Date: 01/25/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1