MAUDE Adverse Event Report: STRYKER SPINE-FRANCE RADIUS ROD TO ROD CONNECTOR 5.5 TO 6.0MM; PEDICLE SCREW SPINAL SYSTEM.

Catalog Number	486614560
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Codes	Injury (2348); No Code Available (3191)
Date of Event	03/26/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient bent over and felt a pop.X-ray confirmed the rod to rod connector pulled out.
Additional Manufacturer Narrative
Method: risk assessment; result: no lot # was provided, so a manufacturing record review could not be performed.Conclusion: because the complaint device was not received and lack of information, the exact cause of the disengagement is unknown.
Event or Problem Description
It was reported that the patient bent over and felt a pop.X-ray confirmed the rod to rod connector pulled out.

• Brand Name: RADIUS ROD TO ROD CONNECTOR 5.5 TO 6.0MM
• Common Device Name: PEDICLE SCREW SPINAL SYSTEM.
• Manufacturer (Section D): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• MDR Report Key: 5756066
• Report Number: 0009617544-2016-00258
• Device Sequence Number: 18948898
• Product Code: MNH
• UDI-Device Identifier: 04546540546364
• UDI-Public: (01)04546540546364
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K070631
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/03/2016

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: 486614560
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 06/03/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/28/2016
• Supplement Report FDA Received Date: 12/13/2016
• 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: 42 YR