MAUDE Adverse Event Report: STRYKER SPINE-SWITZERLAND XIA LP POLYAXIAL SCREW 7.5 X 40MM; SPINAL INTERVERTEBRAL BODY FIXATION ORTHOSIS

Catalog Number	03821740
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/09/2016
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that; during a revision, the patient had hardware in l4-s1.We were extending the hardware up to l3.When the doctor took out old rod and started turning the heads on the screws that were already in the patient, three tulip heads popped off.We replaced them with other screws.
Additional Manufacturer Narrative
Visual inspection; device history review; complaint history review; risk assessment.No relevant manufacturing issues were identified as all units met specifications.According to the ifu, "once implanted, the implants are subjected to stresses and strains.Indeed, the stresses and strains on the implants may cause metal fatigue or fracture or deformation of the implants, before the bone graft has become completely consolidated.While the expected life of spinal implant components is difficult to estimate, it is finite.The components cannot be expected to indefinitely withstand the activity level and loads of normal healthy bone." it is possible the implants became deformed over time and when force was exerted on the tulip heads during repositioning, they disengaged.Additionally, the patient did fuse, so the implants served their purpose.The most likely cause of the event is fatigue of the devices due to the length of implantation.
Event or Problem Description
It was reported that; during a revision, the patient had hardware in l4-s1.We were extending the hardware up to l3.When the doctor took out old rod and started turning the heads on the screws that were already in the patient three tulip heads popped off.We replaced them with other screws.

• Brand Name: XIA LP POLYAXIAL SCREW 7.5 X 40MM
• Common Device Name: SPINAL INTERVERTEBRAL BODY FIXATION ORTHOSIS
• Manufacturer (Section D): STRYKER SPINE-SWITZERLAND; le crêt-du-locle 10 a; -; la chaux-de-fonds 2300 ; CH 2300
• MDR Report Key: 5920658
• Report Number: 3005525032-2016-00100
• Device Sequence Number: 13760521
• Product Code: KWQ
• UDI-Device Identifier: 04546540149305
• UDI-Public: (01)04546540149305
• Combination Product (Y/N): N
• Initial Reporter State: MS
• Initial Reporter Country: US
• PMA/510(K) Number: K060361
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/09/2016

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: 03821740
• Device Lot Number: B00376
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/30/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 08/09/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/01/2016
• Supplement Report FDA Received Date: 11/09/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 83 YR