MAUDE Adverse Event Report: PROVIDENCE MEDICAL TECHNOLOGY, INC. ALLY BONE SCREW-L; INTERVERTEBRAL FUSION DEVICE WITH INTEGRATED FIXATION, CERVICAL

Model Number PD-32-602

Device Problems Defective Component (2292); Material Protrusion/Extrusion (2979)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/15/2019

Event Type  malfunction  

Manufacturer Narrative

The screw malposition occurred due to the use of an undersized screw, exacerbated by the surgeon over-driving the screw into the cage without use of the cage holder instrument, which is supplied with the kit.

Event Description

During completion of a 3 level acdf, c3-c6 , on a (b)(6) female, a surgeon reported mal-position of the superior ally bone screw-l through cavux-l cervical cage at c4-c5 level upon delivery and adjustment with a screw driver without use of the cage holder instrument, resulting in the screw protruding beyond the cage by approximately 2 millimeters.The surgeon removed the screw and replaced it with another screw, resulting is a successful placement.Surgeon experienced similar issue at the c5-c6 level, but the protrusion beyond the cage was minimal, and surgeon did not adjust the screw position.Surgeon reported that overall the procedure was completed successfully, without any negative sequalae.

Manufacturer Narrative

Updated problem description for clarity.From: during completion of a 3 level acdf, c3-c6 , on a 59-year-old female, a surgeon reported mal-position of the superior ally bone screw-l through cavux-l cervical cage at c4-c5 level upon delivery and adjustment with a screw driver without use of the cage holder instrument, resulting in the screw protruding beyond the cage by approximately 2 millimeters.The surgeon removed the screw and replaced it with another screw, resulting is a successful placement.Surgeon experienced similar issue at the c5-c6 level, but the protrusion beyond the cage was minimal, and surgeon did not adjust the screw position.Surgeon reported that overall the procedure was completed successfully, without any negative sequalae.To: during completion of a 3 level acdf, c3-c6 , on a 59-year-old female, a surgeon reported mal-position of the superior ally bone screw-l through cavux cervical cage-l implant at c4-c5 level upon delivery and adjustment with a screw driver without use of the cage delivery instrument, resulting in approximately 3mm of excess protrusion from the intended screw placement position.The surgeon removed the screw and replaced it with another screw, resulting in a successful placement.Surgeon experienced similar issue at the c5-c6 level, but the protrusion beyond the cage was minimal, and surgeon did not adjust the screw position.Surgeon reported that overall the procedure was completed successfully, without any negative clinical sequalae.

Event Description

During completion of a 3 level acdf, c3-c6 , on a 59-year-old female, a surgeon reported mal-position of the superior ally bone screw-l through cavux cervical cage-l implant at c4-c5 level upon delivery and adjustment with a screw driver without use of the cage delivery instrument, resulting in approximately 3mm of excess protrusion from the intended screw placement position.The surgeon removed the screw and replaced it with another screw, resulting in a successful placement.Surgeon experienced similar issue at the c5-c6 level, but the protrusion beyond the cage was minimal, and surgeon did not adjust the screw position.Surgeon reported that overall the procedure was completed successfully, without any negative clinical sequalae.

• Brand Name: ALLY BONE SCREW-L
• Type of Device: INTERVERTEBRAL FUSION DEVICE WITH INTEGRATED FIXATION, CERVICAL
• Manufacturer (Section D): PROVIDENCE MEDICAL TECHNOLOGY, INC.; 3875 hopyard rd. suite 300; pleasanton CA 94588
• MDR Report Key: 8515345
• MDR Text Key: 146359969
• Report Number: 3009394448-2019-00002
• Device Sequence Number: 1
• Product Code: OVE
• UDI-Device Identifier: 00852776006317
• UDI-Public: (01)00852776006317(17)200416(10)045647
• Combination Product (y/n): N
• PMA/PMN Number: K163474
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 04/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/15/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/16/2020
• Device Model Number: PD-32-602
• Device Catalogue Number: PD-32-602
• Device Lot Number: 045647
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/25/2019
• Date Manufacturer Received: 03/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: 3009394448-19-001-R
• Patient Sequence Number: 1
• Treatment: CAVUX SPINAL SYSTEM-L, CAVUX CERVICAL CAGE-L; CAVUX SPINAL SYSTEM-L, CAVUX CERVICAL CAGE-L
• Patient Age: 59 YR