MAUDE Adverse Event Report: ZIMMER SPINE POLYAXIAL PEDICLE SCREW (ÿ 6.5 MM X 35 MM L)

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problem Pain (1994)

Event Type  Injury  

Manufacturer Narrative

Without a product return, no product evaluation is able to be conducted.Current information is insufficient to permit a valid conclusion about the cause of this event.If additional information is obtained that adds value to the relevant content of this report and/or a conclusion can be drawn, a follow-up report will be sent.Report two of four for the same event; see also 0002184052-2016-00109, 00112 and 00113.

Event Description

Legal counsel reported a patient had two ¿harrington rods¿ that were implanted on (b)(6) 2009 to treat a back fracture.The original procedure was orif (open reduction internal fixation) with decompression l1 and bilateral posterolateral arthrodesis t11-l1 with pedicle screws.The patient alleges an x-ray taken on (b)(6) 2015 revealed the right rod had fractured.Patient further alleges pain and injuries to her neck, back, and ¿body as a whole.¿ it is unknown if a revision surgery has been performed.

• Brand Name: POLYAXIAL PEDICLE SCREW (ÿ 6.5 MM X 35 MM L)
• Type of Device: SCREW
• Manufacturer (Section D): ZIMMER SPINE; 7375 bush lake road; minneapolis MN 55439
• Manufacturer (Section G): ZIMMER SPINE; 7375 bush lake road; minneapolis MN 55439
• Manufacturer Contact: michelle cole ; 1520 tradeport drive; jacksonville, FL 32218 ; 9047419468
• MDR Report Key: 5761489
• MDR Text Key: 48530690
• Report Number: 0002184052-2016-00111
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK133086
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Attorney
• Type of Report: Initial
• Report Date: 01/18/2016

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?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 8006535
• Device Lot Number: UNKNOWN
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/18/2016
• Initial Date FDA Received: 06/30/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 44 YR