MAUDE Adverse Event Report: STRYKER SPINE-US XIA 3 TITANIUM ROD TO ROD CONNECTOR SMALL PARALLEL 7MM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number	03805001
Medical Device Problem Code	Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/16/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient was hospitalized for an arthrectomy and osteotomy with arthrodesis for a scoliosis.The device did not hold the 2 rods correctly despite maximum tightening.The device was replaced.Late management of the patient with a delay in the surgery was reported.
Event or Problem Description
It was reported that a patient was hospitalized for an arthrectomy and osteotomy with arthrodesis for a scoliosis.The device did not hold the 2 rods correctly despite maximum tightening.The device was replaced.Late management of the patient with a delay in the surgery was reported.
Additional Manufacturer Narrative
Method: visual inspection, device history review, complaint history review, risk assessment.Result: the customer reported event was not confirmed because the device functioned as expected during inspection.The rod to rod connector was returned with both rods attached to it.A visual inspection was performed and no visual non-conformances were identified.The blockers had full contact with the rods.No deformation was found on the blockers as the hex shape was intact for both.The rods were attempted to be moved, but were stiff and immobile in the connector.No looseness was observed.The rod to rod connector functioned as expected and the reported complaint could not be duplicated.Manufacturing records were reviewed for the corresponding lot and no relevant issues were identified.Conclusion: since no issues were found with the returned product, the reported complaint was unable to be duplicated as the device functioned as expected, a root cause cannot be determined.

• Brand Name: XIA 3 TITANIUM ROD TO ROD CONNECTOR SMALL PARALLEL 7MM
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; -; allendale NJ 07401
• MDR Report Key: 7379620
• Report Number: 3005525032-2018-00016
• Device Sequence Number: 1233562
• Product Code: NKB
• UDI-Device Identifier: 04546540147981
• UDI-Public: (01)04546540147981
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K083393
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 05/30/2018

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: Health Professional
• Device Model Number: 03805001
• Device Catalogue Number: 48230141
• Device Lot Number: B70838
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/02/2018
• Initial Date Received by Manufacturer: 02/27/2018
• Supplement Date Received by Manufacturer: 05/03/2018
• Initial Report FDA Received Date: 03/28/2018
• Supplement Report FDA Received Date: 05/30/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 27 YR
• Patient Weight: 69