MAUDE Adverse Event Report: STRYKER SPINE-US ACP 1 1 LEVEL ANTERIOR CERVICAL PLATE 12MM; SPINAL INTERVERTEBRAL BODY FIXATION ORTHOSIS

Model Number 48803112A

Device Problems Break (1069); Detachment Of Device Component (1104)

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

Event Date 11/14/2017

Event Type  malfunction  

Event Description

It was reported that; locking screw broke off.

Manufacturer Narrative

Manufacturing records for this product were reviewed and no anomalies were found.The representative reported that the locking screw was overtightened.Per surgical technique, "to attach the locking screw to the plate, align the tip of the locking screw with the appropriate screw hole and apply a gentle downward force while rotating the locking screw inserter.The four protrusions at the tip of the locking screw inserter will engage the holes in the head of the locking screw to affix the locking screw to the plate.Continue rotating the locking screw inserter until the locking screw is firmly secured to the plate.Gently rock the inserter to separate the locking screw from its shaft." the most likely root cause is that the locking screw was overtightened, excessive axial/torsional/cantilever force applied to the inserter during screw insertion can cause locking screw breakage.

Event Description

It was reported that; locking screw broke off.

• Brand Name: ACP 1 1 LEVEL ANTERIOR CERVICAL PLATE 12MM
• Type of Device: SPINAL INTERVERTEBRAL BODY FIXATION ORTHOSIS
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• Manufacturer (Section G): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• Manufacturer Contact: margarita karan ; 2 pearl court; allendale, NJ 07401 ; 2017608000
• MDR Report Key: 7112420
• MDR Text Key: 94949307
• Report Number: 3004024955-2017-00042
• Device Sequence Number: 1
• Product Code: KWQ
• UDI-Device Identifier: 07613327122596
• UDI-Public: (01)07613327122596
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K150700
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 48803112A
• Device Catalogue Number: 48803112A
• Device Lot Number: M-60832
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/28/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/03/2015
• 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 Age: 39 YR