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

Model Number	ACP349P
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/05/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient information: unknown.Reporter 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
Information provided indicates that a procedure was performed on (b)(6) 2020 utilizing the simplicity plus acdf system.The anterior cervical plate plus 3-level 49mm (acp349p) was placed with two screws when it was noted that the tip of one of the locking rivets was bent down into the screw hole.The plate was removed and a plate was used from the back-up slimplicity acp system set to successfully complete the procedure, with no harm to the patient.There was a five (5) minute delay to the procedure.
Additional Manufacturer Narrative
H3 device evaluation - engineering performed a visual inspection of the complaint product.The anterior surface of the plate and multiple locking tabs have scratches and chips.It has been noted in this complaint that this plate was a field transfer with little other information provided.It is unknown if the damage occurred during use or was received in the observed condition.Therefore, the root cause for this failure cannot be determined.The device history record for the 17 piece lot, confirms that products had been inspected and conform to drawing specifications.Review of device history records found seventeen (17) pieces of this lot were released for distribution on 10/2/2017 with no deviation or anomalies.Two-year complaint history review (2.5.2018-2.5.2020) found this to be the only report for this part number.As root cause could not be identified and there was not a trend for reports of this nature identified, the need for corrective action is not indicated.
Event or Problem Description
Information provided indicates that a procedure was performed on (b)(6) 2020 utilizing the simplicity plus acdf system.The anterior cervical plate plus 3-level 49mm (acp349p) was placed with two screws when it was noted that the tip of one of the locking rivets was bent down into the screw hole.The plate was removed and a plate was used from the back-up slimplicity acp system set to successfully complete the procedure, with no harm to the patient.There was a five (5) minute delay to the procedure.

• Brand Name: SLIMPLICITY PLUS ANTERIOR CERVICAL PLATING SYSTEM
• Common Device Name: SPINAL FIXATION PLATE
• Manufacturer (Section D): PRECISION SPINE, INC.; 2050 executive dr; pearl MS 39208
• MDR Report Key: 9764977
• Report Number: 3005739886-2020-00008
• Device Sequence Number: 13596245
• Product Code: KWQ
• UDI-Device Identifier: 00840019916202
• UDI-Public: 00840019916202
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K060025
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: ACP349P
• Device Catalogue Number: ACP349P
• Device Lot Number: 15656PS
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/07/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/05/2020
• Supplement Date Received by Manufacturer: 02/05/2020
• Initial Report FDA Received Date: 02/27/2020
• Supplement Report FDA Received Date: 03/11/2020
• 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