MAUDE Adverse Event Report: STRYKER SPINE-US RADIUS 5.5 X 600MM SPINAL ROD WITH HEX; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Catalog Number	486613600
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Injury (2348); No Information (3190)
Date of Event	12/15/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
Surgeon sent picture of patient who originally had a t11-pelvis fusion on (b)(6) 2018.Image shows both rods had popped out of the pelvic screws and the cage at l4-l5 had backed out.Required revision of fusion (screws added at s1; and rods re-seated and revised in pelvic bolts), extraction of cage, and closure of dural tear at l4/l5.
Additional Manufacturer Narrative
Method: labelling review, risk assessment.Result: the customer reported event was confirmed via x-ray by doctor and correspondence.No lot # was provided and cage was discarded, so a manufacturing record review could not be performed.Conclusion: the root cause of the reported event is likely due to lack of enough tightness during supplemental fixation system installation.
Event or Problem Description
Surgeon sent picture of patient who originally had a t11-pelvis fusion on (b)(6) 2018.Image shows both rods had popped out of the pelvic screws and the cage at l4-l5 had backed out.Required revision of fusion (screws added at s1; and rods re-seated and revised in pelvic bolts), extraction of cage, and closure of dural tear at l4/l5.

• Brand Name: RADIUS 5.5 X 600MM SPINAL ROD WITH HEX
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 8244446
• Report Number: 0009617544-2019-00006
• Device Sequence Number: 11378287
• Product Code: NKB
• UDI-Device Identifier: 04546540545831
• UDI-Public: 04546540545831
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K113666
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Catalogue Number: 486613600
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/16/2018
• Supplement Date Received by Manufacturer: 03/29/2019
• Initial Report FDA Received Date: 01/14/2019
• Supplement Report FDA Received Date: 04/15/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 45 YR