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

Model Number	ACP122
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/22/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient information - unknown.Initial reporter occupation - other; sales representative.Device manufacture date - unknown.Without the opportunity to examine the device, no conclusions can be drawn as to the root cause of the reported malfunction.Should the device be received, a follow-up report will be filed upon completion of investigation.Device history records could not be reviewed with lot identity.
Event or Problem Description
It was reported that a procedure was performed on (b)(6) 2021 utilizing the slimplicity anterior cervical system.When positioning one of the locking tabs it became stuck.The anterior cervical plate 1-level 22mm (acp122) was removed and replaced with another readily available in the set.There was a 5-7 minute delay to the procedure because of the reported event.There was no patient injury reported.

• Brand Name: SLIMPLICITY ANTERIOR CERVICAL PLATE SYSTEM
• Common Device Name: SPINAL FIXATION DEVICE
• Manufacturer (Section D): PRECISION SPINE, INC.; 2050 executive dr; pearl MS 39208
• Manufacturer (Section G): PRECISION SPINE, INC.; 2050 executive dr; pearl MS 39208
• Manufacturer Contact: mike dawson ; 2050 executive dr; pearl, MS 39208 ; 6014204244
• MDR Report Key: 12965009
• Report Number: 3005739888-2021-00062
• Device Sequence Number: 19878727
• Product Code: KWQ
• UDI-Device Identifier: 00840019904674
• UDI-Public: 00840019904674
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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
• Report Date (Section B): 11/10/2021

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 Model Number: ACP122
• Device Catalogue Number: ACP122
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/10/2021
• Initial Report FDA Received Date: 12/08/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown