MAUDE Adverse Event Report: STRYKER SPINE-US ACP1 LOCKING SCREW; SPINAL INTERVERTEBRAL BODY FIXATION ORTHOSIS

Catalog Number	48805000A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/25/2016
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that an acdf was being performed.After successfully implanting the plate and the 4 bone screws, the surgeon was inserting the final locking mechanism and tightening the threaded section.As the surgeon tightened it, the threaded section broke away from the locking plate.The surgeon had to remove the other locking mechanism, the 4 screws, and the cervical plate.The surgeon then had to implant a new plate, 4 screws, and 2 locking plates.The surgery ended successfully, without any further delay and without any injury to the patient.
Additional Manufacturer Narrative
Catalog#: 48805000a.Lot#: m-60890.Visual analysis, material analysis, device history review, complaint history review, risk assessment.The customer reported event was confirmed via visual inspection of the returned device.Manufacturing records were reviewed for the corresponding lot and no relevant issues were identified.Material analysis was performed and found that the examined fracture surface exhibited torsional ductile overload consistent with the reported event.The elemental composition was found to be consistent with the material listed on the print.No material or manufacturing defects were found.The most likely cause of the reported event was excessive torsional force applied to the locking screw during insertion as evidenced by the materials analysis performed.
Event or Problem Description
It was reported that an acdf was being performed.After successfully implanting the plate and the 4 bone screws, the surgeon was inserting the final locking mechanism and tightening the threaded section.As the surgeon tightened it, the threaded section broke away from the locking plate.The surgeon had to remove the other locking mechanism, the 4 screws, and the cervical plate.The surgeon then had to implant a new plate, 4 screws, and 2 locking plates.The surgery ended successfully, without any further delay and without any injury to the patient.

• Brand Name: ACP1 LOCKING SCREW
• Common Device Name: SPINAL INTERVERTEBRAL BODY FIXATION ORTHOSIS
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 5665003
• Report Number: 3004024955-2016-00050
• Device Sequence Number: 10846988
• Product Code: KWQ
• UDI-Device Identifier: 07613327122442
• UDI-Public: (01)07613327122442
• Combination Product (Y/N): N
• Initial Reporter State: MS
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/25/2016

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 Catalogue Number: 48805000A
• Device Lot Number: M-60890
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/10/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 04/25/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/18/2016
• Supplement Report FDA Received Date: 11/03/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 65 YR