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

Model Number	PD-32-602
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/15/2019
Type of Reportable Event	Malfunction
Additional 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 or Problem 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.
Additional 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 or Problem 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
• Common Device Name: 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
• Report Number: 3009394448-2019-00002
• Device Sequence Number: 1871085
• Product Code: OVE
• UDI-Device Identifier: 00852776006317
• UDI-Public: (01)00852776006317(17)200416(10)045647
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K163474
• 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,distri
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall,Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/11/2019

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 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/15/2019
• Supplement Date Received by Manufacturer: 03/15/2019
• Initial Report FDA Received Date: 04/15/2019
• Supplement Report FDA Received Date: 05/08/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 3009394448-19-001-R
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CAVUX SPINAL SYSTEM-L, CAVUX CERVICAL CAGE-L; CAVUX SPINAL SYSTEM-L, CAVUX CERVICAL CAGE-L
• Patient Age: 59 YR