MAUDE Adverse Event Report: PARAMOUNT ANCHOR PLATE PULL ROD; INSERTER INSTRUMENT

Lot Number	924P07-011
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/20/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This event was reported by the user facility as report # (b)(4) received from fda through sus voluntary event reporting.Attempts to obtain the device from the hospital were unsuccessful; the device was not made available for evaluation.Review of the dhr found no device issues for the indentified production lot.Not returned to mfg for evaluation.
Event or Problem Description
This event was reported on uf/importer report # (b)(4).The surgeon has reported the patient is recovering satisfactorily.

• Brand Name: PARAMOUNT ANCHOR PLATE PULL ROD
• Common Device Name: INSERTER INSTRUMENT
• MDR Report Key: 6862758
• Report Number: 3004638600-2017-00006
• Device Sequence Number: 18990931
• Product Code: OVE
• UDI-Device Identifier: 10840642111767
• UDI-Public: 10840642111767
• Combination Product (Y/N): N
• PMA/510(K) Number: K162760
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Physician
• Device Lot Number: 924P07-011
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/21/2017
• Initial Report FDA Received Date: 09/13/2017
• Patient Sequence Number: 1