MAUDE Adverse Event Report: STRYKER SPINE-US ACP 1 VARIABLE SELF TAPPING BONE SCREW SET DIA 4.0X14MM; SPINAL INTERVERTEBRAL BODY FIXATION ORTHOSIS.

Model Number	48804414A
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); Device Embedded In Tissue or Plaque (3165)
Date of Event	06/28/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during insertion the threaded portion of the locking mechanism broke off in the plate.Surgeon decided against removing the screws and replacing plate (per rep's suggestion).Threaded portion is stuck in the plate inside the patient.Other piece of the locking mechanism will be returned.
Additional Manufacturer Narrative
Method: visual inspection, functional inspection, device history review, complaint history review, risk assessment.The customer reported event was confirmed via visual inspection.The device was found to be fractured.Manufacturing history was reviewed and no issues were identified.A root cause of the event was determined to be excessive torsional force applied to the locking screw during insertion.
Event or Problem Description
It was reported that during insertion the threaded portion of the locking mechanism broke off in the plate.Surgeon decided against removing the screws and replacing plate (per rep's suggestion).Threaded portion is stuck in the plate inside the patient.Other piece of the locking mechanism will be returned.

• Brand Name: ACP 1 VARIABLE SELF TAPPING BONE SCREW SET DIA 4.0X14MM
• Common Device Name: SPINAL INTERVERTEBRAL BODY FIXATION ORTHOSIS.
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 6737554
• Report Number: 3004024955-2017-00031
• Device Sequence Number: 832065
• Product Code: KWQ
• UDI-Device Identifier: 07613327122275
• UDI-Public: (01)07613327122275
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/08/2017

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: 48804414A
• Device Catalogue Number: 48804414A
• Device Lot Number: M62699
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/17/2017
• Initial Date Received by Manufacturer: 06/28/2017
• Supplement Date Received by Manufacturer: 06/28/2017
• Initial Report FDA Received Date: 07/24/2017
• Supplement Report FDA Received Date: 11/08/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 51 YR