MAUDE Adverse Event Report: ENCORE MEDICAL, L.P. RSP SHOULDER; SCREW, LOCKING BONE, RSP, 5X14

Model Number	506-03-114
Health Effect - Clinical Codes	Unspecified Infection (1930); Pain (1994)
Date of Event	03/01/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision surgery - due to the patient complaining of pain and possible infection.

• Brand Name: RSP SHOULDER
• Common Device Name: SCREW, LOCKING BONE, RSP, 5X14
• Manufacturer (Section D): ENCORE MEDICAL, L.P.; 9800 metric blvd.; austin TX 78758
• MDR Report Key: 5523528
• Report Number: 1644408-2016-00205
• Device Sequence Number: 14414141
• Product Code: KWS
• UDI-Device Identifier: 00888912024532
• UDI-Public: (01)00888912024532
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K041066
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date (Section B): 03/01/2016

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: 506-03-114
• Device Catalogue Number: 506-03-114
• Device Lot Number: 831C1142
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/01/2016
• Initial Report FDA Received Date: 03/24/2016
• 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: 81 YR