MAUDE Adverse Event Report: PRECISION SPINE, INC. SLIMPLICITY ANTERIOR CERVICAL PLATE SYSTEM; SELF DRILLING VARIABLE SCREW

Catalog Number	SDV4014
Health Effect - Clinical Code	No Information (3190)
Date of Event	08/13/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient information - unknown.Occupation - other; sales representative.Evaluation in process but not yet complete.Upon completion of evaluation, a follow up report will be submitted.This report is number 2 of 2 mdrs filed for the same event (reference 3005739886-2015-00036 / 00037).
Event or Problem Description
It was reported that the patient underwent initial implantation on (b)(6) 2019 utilizing the simplicity anterior cervical plate system.Revision was performed on (b)(6) 2019 to address back out of two (2) 4.0mm x 14mm sd variable screws (sdv4014) from the c7 segment.All hardware was removed and replaced.Radiograph provided shows two screws backed out of the bone but not backed out of the plate.Following receipt of explanted product it was identified that none of the locking tabs on the plate are broken.
Additional Manufacturer Narrative
H3 device evaluation - review of the radiographic image shows the cervical plate spanning three levels.Only two of the four vertebral bodies were instrumented with screws because of a previous implantation in the middle level, preventing instrumentation from being possible.A root-cause of the failure could not be determined as there was no damage to the instrumentation.Review of device history records found 499 pcs.Of this lot were released for distribution on (b)(6) 2019 with no deviation or anomalies.Two-year complaint history review (8.15.2017-8.15.2019) found this to be the only report of this nature for this part number.The need for corrective action was not identified as the exact root cause could not be determined and there was no trend identified for reports of this nature.This report is number 2 of 2 mdrs filed for the same event (reference 3005739886-2019-00036-1 / 00037-1).

• Brand Name: SLIMPLICITY ANTERIOR CERVICAL PLATE SYSTEM
• Common Device Name: SELF DRILLING VARIABLE SCREW
• Manufacturer (Section D): PRECISION SPINE, INC.; 2050 executive dr; pearl MS 39208
• MDR Report Key: 8983991
• Report Number: 3005739886-2019-00037
• Device Sequence Number: 235495
• Product Code: KWQ
• UDI-Device Identifier: 00840019905206
• UDI-Public: 00840019905206
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K060025
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/13/2019

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: SDV4014
• Device Lot Number: 23049PS
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/20/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/13/2019
• Supplement Date Received by Manufacturer: 08/13/2019
• Initial Report FDA Received Date: 09/10/2019
• Supplement Report FDA Received Date: 10/16/2019
• 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: 60 YR