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

Model Number	48803112A
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/14/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that; locking screw broke off.
Additional 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 or Problem Description
It was reported that; locking screw broke off.

• Brand Name: ACP 1 1 LEVEL ANTERIOR CERVICAL PLATE 12MM
• Common Device Name: SPINAL INTERVERTEBRAL BODY FIXATION ORTHOSIS
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 7112420
• Report Number: 3004024955-2017-00042
• Device Sequence Number: 1629559
• Product Code: KWQ
• UDI-Device Identifier: 07613327122596
• UDI-Public: (01)07613327122596
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K150700
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Model Number: 48803112A
• Device Catalogue Number: 48803112A
• Device Lot Number: M-60832
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/14/2017
• Supplement Date Received by Manufacturer: 02/28/2018
• Initial Report FDA Received Date: 12/13/2017
• Supplement Report FDA Received Date: 03/29/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 39 YR