MAUDE Adverse Event Report: PRECISION SPINE, INC SLIMPLICITY ANTERIOR CERVICAL PLATE 2-LEVEL; SPINAL INTERVERTEBRAL FIXATION ORTHOSIS ANTERIOR CERVICAL PLATE SYSTEM

Catalog Number ACP2XX

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

Patient Problem No Code Available (3191)

Event Date 04/04/2016

Event Type  Injury  

Manufacturer Narrative

Device evaluation was not possible as the broken tab piece was discarded by the user facility and the plate remains implanted.Without lot identification, manufacturing history review and lot specific complaint history review were not possible.A two-year review of complaint history for all part numbers in the acpxxx family of slimplicity anterior cervical plates did not identify a trend for reports of this nature.The slimplicity anterior cervical plate system instruction for use (ifu) lbl-ifu-005, states under potential adverse affects: "bending, loosening, fracture, disassembly, slippage and/or migration of components" and under warnings "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" as root cause could not be determined and no trend was identified, the need for corrective action was not indicated.

Event Description

It was reported that the patient underwent spinal fusion utilizing the slimplicity anterior cervical plating system in (b)(6) of 2015.At approximately 6 months post-operative it was identified that one of the locking rivets of the anterior cervical plate (acp2xx) had broken and the screw had begun to back out.Revision was performed on (b)(6) 2016 during which the broken locking tab and one 4.0mm x 16mm sd fixed screw (sdf4016) were removed.The remaining screws and plate were left in place.The fusion had healed.

• Brand Name: SLIMPLICITY ANTERIOR CERVICAL PLATE 2-LEVEL
• 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: 5625703
• MDR Text Key: 44283617
• Report Number: 3005739886-2016-00020
• 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: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/04/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/03/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Catalogue Number: ACP2XX
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/04/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Required Intervention