MAUDE Adverse Event Report: PRECISION SPINE, INC ANTERIOR CERVICAL PLATE 1-LEVEL 24MM; SPINAL INTERVERTEBRAL FIXATION ORTHOSIS ANTERIOR CERVICAL PLATE SYSTEM

Catalog Number ACP124

Device Problems Device Slipped (1584); Device Operates Differently Than Expected (2913)

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

Event Type  malfunction  

Manufacturer Narrative

Device evaluation was not possible as the product remains implanted.A two-year complaint history review did not reveal a trend for reports of this nature.Without the ability to examine the affected plate, the root cause of the reported issue could not be determined.As the 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 after bending the anterior cervical plate 1-level 24mm (acp124), the locking rivets were disabled.The plate was implanted with the screws backed out enough to put tension on the locking rivets.

• Brand Name: ANTERIOR CERVICAL PLATE 1-LEVEL 24MM
• 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: 5853412
• MDR Text Key: 51374454
• Report Number: 3005739886-2016-00039
• 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
• Report Date: 07/14/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: ACP124
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/14/2016
• 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