MAUDE Adverse Event Report: PIONEER SURGICAL (D.B.A. RTI SURGICAL) PIONEER SURGICAL STREAMLINE TL CROSSLINK; SPINAL ROD FIXATION CROSSLINK

Model Number UNKNOWN

Device Problem Break (1069)

Patient Problem Intraoperative Pain (2662)

Event Date 07/12/2016

Event Type  Injury  

Manufacturer Narrative

The explanted device was not returned to pioneer surgical for evaluation.It is unknown if the patient's non-fusion over the 3 years the device was implanted caused this occurrence.However, it is likely that this contributed to this break of the device.Delayed union and non-union are two of the risks identified in the instructions for use that is supplied with this device when it is distributed to the customer.The ifu states that " implants can break when subjected to the increased loading associated with delayed union or non-union".In this case it was reported that the patient did not experience union in 3 years.

Event Description

Three years after the initial posterior spinal rod fixation surgery the patient did not have fusion.During the revision surgery to add a level to the original construct it was observed that the crosslink that attaches to either side of the construct had broken.This device was removed from the patient.

• Brand Name: PIONEER SURGICAL STREAMLINE TL CROSSLINK
• Type of Device: SPINAL ROD FIXATION CROSSLINK
• Manufacturer (Section D): PIONEER SURGICAL (D.B.A. RTI SURGICAL); 375 river park circle; marquette MI 49855
• Manufacturer (Section G): PIONEER SURGICAL (D.B.A. RTI SURGICAL); 375 river park circle; marquette MI 49855
• Manufacturer Contact: dan nelson ; 375 river park circle; marquette, MI 49855 ; 9062264489
• MDR Report Key: 5868263
• MDR Text Key: 51844286
• Report Number: 1833824-2016-00029
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K140696
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/11/2016

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
• Device Operator: Physician
• Device Model Number: UNKNOWN
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/12/2016
• Initial Date FDA Received: 08/11/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention