MAUDE Adverse Event Report: CAPTIVA SPINE CAPLOX II PEDICLE SCREW SYSTEM; PEDICLE SCREW SPINAL SYSTEM

Model Number	2431-6545
Medical Device Problem Codes	Break (1069); Material Integrity Problem (2978)
Health Effect - Clinical Code	Patient Problem/Medical Problem (2688)
Date of Event	12/21/2015
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device not returned to the manufacturer.
Event or Problem Description
During the primary surgery ((b)(6) 2015), the surgeon placed bilateral 6.5 x 45mm pedicle screws in the sacrum and spanned the l5 pedicle to place bilateral 6.5 x 50mm pedicle screws in the l4 pedicles.It was reported that the patient fell off a gurney on the second day post-op.During the six month follow up visit ((b)(6) 2015), an x-ray identified two broken 6.5 x 45mm screws in the sacrum.As a result, the surgeon ordered a ct scan and determined that a revision surgery was appropriate.The revision surgery ((b)(6) 2015) included pedicle screws at each level from l4, l5 and the sacrum.During the one month follow up ((b)(6) 2016), the surgeon indicated that the patient is doing well.

• Brand Name: CAPLOX II PEDICLE SCREW SYSTEM
• Common Device Name: PEDICLE SCREW SPINAL SYSTEM
• Manufacturer (Section D): CAPTIVA SPINE; 967 alternate a1a suite 1; jupiter FL 33477
• MDR Report Key: 5386946
• Report Number: 3006082533-2016-00001
• Device Sequence Number: 223728
• Product Code: MNH
• UDI-Device Identifier: M73924316545
• UDI-Public: M73924316545
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K120292
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Report Date (Section B): 01/22/2016

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?: No
• Operator of Device: Health Professional
• Device Model Number: 2431-6545
• Device Catalogue Number: 2431-6545
• Device Lot Number: 04141063
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/22/2016
• 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: 60 YR