MAUDE Adverse Event Report: STRYKER SPINE-FRANCE REFLEX-HYBRID 1 LEVEL ACP SIZE 14MM; SPINAL INTERVERTEBRAL BODY FIXATION ORTHOSIS.

Model Number	48651114
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/05/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that: the patient supine, the conventional surgical disinfection shop towels, full clear surgical field exposure, regular line of anterior cervical decompression, into the intervertebral fusion, did not lock, perspective, steel plate position, then remove the screw order, but found that screw can't take out, can only take out as a whole.
Additional Manufacturer Narrative
Method: visual inspection, device history review, complaint history review, risk assessment; result: the reported event was confirmed visually to have two screws stuck in the locking ring.No manufacturing issues were found for this lot number.No information is available on how the screw holes were prepared.Possible root causes include: insufficient visibility.Screw hole too shallow.Plate/screw were previously used as a demo.Excessive axial/torsional force applied during screw insertion.
Event or Problem Description
It was reported that: the plate did not lock.The screws could not be removed and the whole plate was taken out.There are no reports of adverse health consequences to the patient.

• Brand Name: REFLEX-HYBRID 1 LEVEL ACP SIZE 14MM
• Common Device Name: SPINAL INTERVERTEBRAL BODY FIXATION ORTHOSIS.
• Manufacturer (Section D): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• MDR Report Key: 7199852
• Report Number: 0009617544-2018-00014
• Device Sequence Number: 722658
• Product Code: KWQ
• UDI-Device Identifier: 04546540534729
• UDI-Public: (01)04546540534729
• Combination Product (Y/N): N
• Initial Reporter Country: CN
• PMA/510(K) Number: K040261
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• 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: 48651114
• Device Catalogue Number: 48651114
• Device Lot Number: 175599
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/02/2018
• Initial Date Received by Manufacturer: 12/21/2017
• Supplement Date Received by Manufacturer: 02/28/2018
• Initial Report FDA Received Date: 01/17/2018
• 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