MAUDE Adverse Event Report: PRECISION SPINE, INC SLIMPLICITY ANTERIOR CERVICAL PLATE 3-LEVEL 63MM; SPINAL INTERVERTEBRAL FIXATION ORTHOSIS ANTERIOR CERVICAL PLATE SYSTEM

Catalog Number ACP363

Device Problems Break (1069); Device Slipped (1584)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/02/2016

Event Type  malfunction  

Manufacturer Narrative

Device evaluation not possible as the device remains implanted.The investigation is in process but not yet complete.Upon completion, a follow up report will be submitted.Device remains implanted.

Event Description

It was reported that the simplicity acp plate and screws were implanted on (b)(6) 2014.Subsequently, radiographs taken on or around (b)(6) 2016 indicate that one of the locking rivets at the c6 level has broken and the screw has begun to back out.There are no plans to remove any hardware at this time.

Manufacturer Narrative

Device evaluation was not possible as the product remains implanted.There have been no clinical issues reported as of the completion of this investigation.Information and radiographs provided were reviewed by engineering and precision spine's internal medical officer.No evidence was found that the product did not meet specifications.No trend was identified and root cause could not be determined therefore, a need for corrective action is not indicated review of manufacturing history records found a total of (b)(4) pieces of lot 1207fm were released for distribution on august 13, 2012 with no deviation or anomalies.A three year complaint history review did not find any previous reports of this nature for the reported lot.Further review for all part numbers in the acpxxxx family of simplicity anterior cervical plates did not identify a trend for reports of locking rivet failure.The simplicity anterior cervical plate system instruction for use (ifu) lbl-ifu-005, states under potential adverse affects: "8.Bending, loosening, fracture, disassembly, slippage and/or migration of components" and under warnings "2.Potential risks identified with the use of this device system, which may require additional surgery, include device component fracture, loss of fixation, non-union, fracture of the vertebrae, necrosis of the bone, neurological injury, and/or vascular injury.".

• Brand Name: SLIMPLICITY ANTERIOR CERVICAL PLATE 3-LEVEL 63MM
• Type of Device: SPINAL INTERVERTEBRAL FIXATION ORTHOSIS ANTERIOR CERVICAL PLATE SYSTEM
• Manufacturer (Section D): PRECISION SPINE, INC; 2050 executive drive; pearl MS 39208
• Manufacturer (Section G): PRECISION SPINE, INC; 2050 executive drive; pearl MS 39208
• Manufacturer Contact: beth albert ; 2050 executive drive; pearl, MS 39208 ; 6014204244
• MDR Report Key: 5484813
• MDR Text Key: 40048177
• Report Number: 3005739886-2016-00007
• Device Sequence Number: 1
• Product Code: KWQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K060025
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/03/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: ACP363
• Device Lot Number: 1207FM
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/03/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/13/2012
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1