MAUDE Adverse Event Report: PRECISION SPINE, INC. SLIMPLICITY PLUS ANTERIOR CERVICAL PLATING SYSTEM; ANTERIOR CERVICAL PLATE

Catalog Number	ACP343P
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.
Event or Problem Description
It was reported that the patient underwent initial procedure on (b)(6) 2019 utilizing the simplicity anterior cervical plate system.Revision was performed on (b)(6) 2019 to address backout of two (2) 4.0mm x 14mm variable screws (66-sv-4014) from the anterior cervical plate plus 3-level 43mm (acp343p).All hardware was remove and replaced.Radiograph received shows two screws backed out of the plate.
Additional Manufacturer Narrative
Device evaluation - evaluation of the returned implant did not demonstrated signs of the screw blockers failing.Typical screw back-out failures would show signs of a fractured or loose blocker.However the blockers are intact and rigidly affixed in their orientation on the plate.A root-cause of the failure could not be determined as there was no damage to the instrumentation.Review of device history record found 15 pieces of this lot were released for distribution on 07/02/2018 with no deviation or anomalies.Two-year complaint history review found this to be the only complaint for this part number.As the root cause could not be determined and this is the first report of this nature for this part number the need for corrective action was not indicated.
Event or Problem Description
It was reported that the patient underwent initial procedure on (b)(6) 2019 utilizing the slimplicity anterior cervical plate system.Revision was performed on august 13, 2019 to address backout of two (2) 4.0mm x 14mm variable screws (66-sv-4014) from the anterior cervical plate plus 3-level 43mm (acp343p).All hardware was remove and replaced.Radiograph received shows two screws backed out of the plate.

• Brand Name: SLIMPLICITY PLUS ANTERIOR CERVICAL PLATING SYSTEM
• Common Device Name: ANTERIOR CERVICAL PLATE
• Manufacturer (Section D): PRECISION SPINE, INC.; 2050 executive dr; pearl MS 39208
• MDR Report Key: 8984318
• Report Number: 3005739886-2019-00038
• Device Sequence Number: 3380175
• Product Code: KWQ
• UDI-Device Identifier: 00840019916189
• UDI-Public: 00840019916189
• 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: ACP343P
• Device Lot Number: 18533PS
• 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: 10/17/2019
• 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: 68 YR