MAUDE Adverse Event Report: SPINE WAVE, INC. CAPSURE® PS3 SCREW ASSEMBLY; PEDICLE SCREW

Catalog Number	11-3747
Health Effect - Clinical Codes	Pain (1994); No Code Available (3191)
Date of Event	02/21/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient reported pain approximately 6 months post-operatively.Imaging showed evidence of a single broken pedicle screw at the s1 level.A procedure was performed to remove and replace both screws at the s1 level and extend the construct for increased fixation.
Additional Manufacturer Narrative
Description of evaluation: a broken screw was returned.A microscopic visual examination was performed which found striations on the break surface indicative of fatigue.Based on the results of our evaluation, we cannot determine the exact cause of the difficulty reported.

• Brand Name: CAPSURE® PS3 SCREW ASSEMBLY
• Common Device Name: PEDICLE SCREW
• Manufacturer (Section D): SPINE WAVE, INC.; 3 enterprise drive; suite 210; shelton CT 06484
• MDR Report Key: 6424936
• Report Number: 3004638600-2017-00001
• Device Sequence Number: 19079314
• Product Code: MNH
• UDI-Device Identifier: 10840642105162
• UDI-Public: 10840642105162
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K111913
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/21/2017

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: Physician
• Device Catalogue Number: 11-3747
• Device Lot Number: 661M26
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/04/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 02/21/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/22/2017
• Supplement Report FDA Received Date: 05/09/2017
• 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