MAUDE Adverse Event Report: ZIMMER SPINE INSTINCT JAVA POLYAXIAL PEDICLE SCREW DG 35

Model Number N/A

Device Problem Fracture (1260)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 01/17/2014

Event Type  Injury  

Manufacturer Narrative

Current information is insufficient to permit a valid conclusion about the cause of this event.A follow up report will be sent upon completion of the device evaluation.Report one of five for the same event, reference 3003853072-2016-00094 through 3003853072-2016-00097.

Event Description

It is reported the initial surgery l5-s1 arthrodesis was performed (b)(6) 2012.Four screws, two rods, and four blockers were implanted.During a routine follow up x-ray on (b)(6) 2014 a broken screw was discovered.The patient began having pain in 2015.On (b)(6) 2016 a revision surgery was performed due to pain.The broken screw was in the pedicle of s1.Fusion did not occur.All hardware was removed and replaced, however a portion of the screw remained in the patient.The patient was fixated l4,-l5 and ilium using a different system.

Manufacturer Narrative

A review of the returned device confirmed that it broke.A review of the manufacturing records did not reveal any issues which would have contributed to this event.The ifu was reviewed and found to contain post-operative instructions, including recommendations for post-operative follow-up to avoid an absence or delay of fusion.

• Brand Name: INSTINCT JAVA POLYAXIAL PEDICLE SCREW DG 35
• Type of Device: SCREW
• Manufacturer (Section D): ZIMMER SPINE; 23 parvis des chartrons; cite mondiale; bordeaux 33080 ; FR 33080
• Manufacturer (Section G): ZIMMER SPINE; 23 parvis des chartrons; cite mondiale; bordeaux 33080 ; FR 33080
• Manufacturer Contact: michelle cole ; 1520 tradeport drive; jacksonville, FL 32218 ; 9047419468
• MDR Report Key: 5772233
• MDR Text Key: 48848758
• Report Number: 3003853072-2016-00093
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: PK111301
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/29/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/06/2016
• 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: 046W0AN27535
• Device Lot Number: H12377B
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/21/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/17/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/19/2010
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 63 YR
• Patient Weight: 60