MAUDE Adverse Event Report: STRYKER SPINE-LEESBURG DEFORMITY UNIPLANAR SCREW; SIZE 6.5X40 MM; THOROCOLUMBOSACRAL PEDICLE SCREW SYSTEM

Catalog Number	3001-36540
Health Effect - Clinical Code	Injury (2348)
Date of Event	12/03/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent revision surgery due to a mesa uniplanar screw which broke at the shaft post-operatively.

• Brand Name: DEFORMITY UNIPLANAR SCREW; SIZE 6.5X40 MM
• Common Device Name: THOROCOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): STRYKER SPINE-LEESBURG; 600 hope parkway se; leesburg, VA 20175
• MDR Report Key: 8800429
• Report Number: 3004774118-2019-01067
• Device Sequence Number: 10848542
• Product Code: NKB
• UDI-Device Identifier: 10888857050099
• UDI-Public: 10888857050099
• Combination Product (Y/N): N
• PMA/510(K) Number: K141873
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/17/2019

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: Health Professional
• Device Catalogue Number: 3001-36540
• Device Lot Number: FCYV
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/17/2019
• Initial Report FDA Received Date: 07/17/2019
• 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