MAUDE Adverse Event Report: PRECISION SPINE, INC ANTERIOR CERVICAL PLATE 1-LEVEL 20MM; SPINAL INTERVERTEBRAL FIXATION ORTHOSIS ANTERIOR CERVICAL PLATE SYSTEM

Catalog Number ACP120

Device Problem Device Slipped (1584)

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

Event Date 12/02/2016

Event Type  Injury  

Manufacturer Narrative

Evaluation was not possible as it has not been returned to the manufacturer.Should the device be returned a follow-up report will be filed.As the lot number was not provided, device history and lot specific complaint history review were not possible.Two-year complaint history review for all part numbers in the acpxxx family of slimplicity anterior cervical plates did not find any previous reports of this nature.No conclusions could be drawn based on the information provided.Device not returned to manufacturer.

Event Description

During a procedure performed on (b)(6) 2016, upon attempt to lock one of the locking rivets on a anterior cervical plate 1-level 20mm (acp120), the locking rivet popped off of the plate.The plate was removed and replaced with another plate with no further issue.

Manufacturer Narrative

Quality evaluation of the returned plate found both dimensions that affect mating of rivet with plate to be within tolerance.All plates of lot 8032ps were 100% inspected during manufacturing process for these two dimensions.Visual review/inspection of the simplicity anterior cervical plate 1-level 20mm (acp120) returned showed no obvious signs of damage to the plate that would cause the rivet to fail.The surgeon had indicated that screw may have been a little proud which may be a result of over angulation of the screw.Attempting to lock/rotate the locking rivets over a proud screw could cause the fracturing of the rivet due to a ramping effect.With the information/product provided, a proud screw is believed to be the root cause of failure.Review of manufacturing history records found a total of (b)(4) pieces of lot 8032ps were released for distribution in january 2016, with no deviation or anomalies.Two-year complaint history review did not reveal any complaints of locking rivets breaking during implantation.As the root cause is attributed to technique, and there is not a trend for reports of this nature, the need for corrective action was not indicated.

• Brand Name: ANTERIOR CERVICAL PLATE 1-LEVEL 20MM
• 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: 6190544
• MDR Text Key: 62912104
• Report Number: 3005739886-2016-00070
• 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: 12/05/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Catalogue Number: ACP120
• Device Lot Number: 8032PS
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/03/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/05/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/27/2016
• 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