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

Catalog Number	48805000A
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Information (3190)
Date of Event	09/09/2016
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that; the locking screw snapped below the locking cover while customer was tightening locking screw.
Additional Manufacturer Narrative
Method: device history review; complaint history review; risk assessment; results: manufacturing records were not reviewed because no parts or lot were provided.Conclusion: the most likely cause of the reported event was excessive torsional force applied to the locking screw during insertion as reported by the stryker rep.
Event or Problem Description
It was reported that; the locking screw snapped below the locking cover while customer was tightening locking screw.

• 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: 5995349
• Report Number: 3004024955-2016-00092
• Device Sequence Number: 13475912
• Product Code: KWQ
• UDI-Device Identifier: 07613327122534
• UDI-Public: (01)07613327122534
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: K150700
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/09/2016

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: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 09/09/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/03/2016
• Supplement Report FDA Received Date: 12/09/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 50 YR
• Patient Weight: 100