MAUDE Adverse Event Report: STRYKER SPINE-FRANCE XIA 3 TITANIUM BLOCKER; PEDICLE SCREW SPINAL SYSTEM

Model Number	48233640
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Code Available (3191)
Date of Event	04/25/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that; during revision surgery- was noted by surgeon that there was rod slippage.Update 5/23/2017.The reason for the revision surgery was due to pseudoarthritis, non fusion.When the surgeon went in to treat the pseudoarthritis, the rod slippage was noticed.Prior to the revision surgery, there was no indication/issue noticed involving any of the previous implanted products.
Additional Manufacturer Narrative
Catalog# 48230000, lot# elc.D date of explant: (b)(6) 2017.Visual inspection, device history review, complaint history review, risk assessment.Manufacturing records were reviewed for the corresponding lot and no relevant issues were identified.The visual inspection of the blockers confirmed indentations at the base of blockers.The most likely root cause of the event is the activity level of the patient along with rod not fully seated in the screw leading to rod slippage.
Event or Problem Description
It was reported that; during revision surgery- was noted by surgeon that there was rod slippage.Update (b)(6) 2017.The reason for the revision surgery was due to pseudoarthritis, non fusion.When the surgeon went in to treat the pseudoarthritis, the rod slippage was noticed.Prior to the revision surgery, there was no indication/issue noticed involving any of the previous implanted products.

• Brand Name: XIA 3 TITANIUM BLOCKER
• Common Device Name: PEDICLE SCREW SPINAL SYSTEM
• Manufacturer (Section D): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• MDR Report Key: 6586503
• Report Number: 0009617544-2017-00218
• Device Sequence Number: 18913118
• Product Code: MNI
• UDI-Device Identifier: 07613327001150
• UDI-Public: (01)07613327001150
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K113666
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/24/2017

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: 48233640
• Device Catalogue Number: 48230000
• Device Lot Number: ELC
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/05/2017
• Initial Date Received by Manufacturer: 04/25/2017
• Supplement Date Received by Manufacturer: 04/25/2017
• Initial Report FDA Received Date: 05/23/2017
• Supplement Report FDA Received Date: 07/24/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 21 YR
• Patient Weight: 69