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 Codes	Mechanical Problem (1384); Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Injury (2348); No Code Available (3191)
Date of Event	06/02/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery was performed from (b)(6) case.Rods pulled out from 5.5-6.0 connectors.When following up on case with surgeon, it was stated that this is the third time this has happened with the same connectors.The sales rep do not have knowledge or previous cases.
Additional Manufacturer Narrative
Lot# 14a085.Results: manufacturing records were reviewed for the corresponding lot and no relevant issues were identified.The patient has the clinical history/medical records of idiopathic scoliosis and extension of previous fusion to pelvis.When the patient bent over to tie shoe a pop was heard.Loading conditions, patient anatomy, the integrity of the screw-rod engagement during surgery; the patient's activity like bending over to tie shoe after the surgery and his previous clinical history can be likely causes.Conclusion: the exact cause of the disengagement is unknown.
Event or Problem Description
It was reported that a revision surgery was performed from (b)(6) case.Rods pulled out from 5.5-6.0 connectors.When following up on case with surgeon, it was stated that this is the third time this has happened with the same connectors.The sales rep do not have knowledge or previous cases.

• 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: 5753183
• Report Number: 0009617544-2016-00257
• Device Sequence Number: 24026
• Product Code: MNH
• UDI-Device Identifier: 04546540546364
• UDI-Public: (01)04546540546364
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K070631
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• 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: 14A085
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/14/2016
• 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: 06/27/2016
• Supplement Report FDA Received Date: 09/19/2016
• 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: 37 YR