MAUDE Adverse Event Report: STRYKER SPINE-US ACP 1 VARIABLE SELF DRILLING BONE SCREW SET DIA 4.0X16MM; SPINAL INTERVERTEBRAL BODY FIXATION ORTHOSIS

Model Number 2110-0039

Device Problems Break (1069); Material Integrity Problem (2978)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Information (3190)

Event Date 10/30/2017

Event Type  malfunction  

Event Description

It was reported that; locking screw broke in plate.Update 10/31/2017: event occured during surgery.

Manufacturer Narrative

Medical products: catalog# 48804316a, lot# m-61282.Method: visual inspection;device history review; complaint history review; risk assessment; results: manufacturing records were reviewed for the corresponding lot and no relevant issues were identified.Conclusion: the probable root cause is lack of preparation of the screw hole as recommended by the stg.

Event Description

It was reported that; locking screw broke in plate.Update 10/31/2017: event occured during surgery.

• Brand Name: ACP 1 VARIABLE SELF DRILLING BONE SCREW SET DIA 4.0X16MM
• 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: christa marrow ; 2 pearl court; allendale, NJ 07401 ; 2017608000
• MDR Report Key: 7049722
• MDR Text Key: 93206292
• Report Number: 3004024955-2017-00040
• Device Sequence Number: 1
• Product Code: KWQ
• UDI-Device Identifier: 00808232001372
• UDI-Public: (01)00808232001372
• 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: user facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 2110-0039
• Device Catalogue Number: 48804316A
• Device Lot Number: M-61282
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/14/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/30/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/30/2015
• 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: 55 YR