MAUDE Adverse Event Report: ZIMMER SPINE UNIVERSAL CLAMP 5.5MM TI; ABBOTT SPINE UNIVERSAL CLAMP SYSTEM

Model Number N/A

Device Problem Material Deformation (2976)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/07/2016

Event Type  Injury  

Manufacturer Narrative

Without a product return, no product evaluation is able to be conducted.The lot number is unknown; therefore the device history records are unable to be reviewed.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.Device thrown away due to biohazard.

Event Description

During a deformity correction surgery, a universal clamp being used for sequential reduction failed.This caused the construct to loosen and new clamp tape had to be applied.The surgery was completed at this point with no further issues.No patient injury was reported.

Manufacturer Narrative

Lot number: 2858333 or 2869354.Additional information: method code.The device was not returned for evaluation.The device is believed to be one of two lot numbers.The dhrs for both lot numbers were reviewed; there were no discrepancies detected which would have contributed to this event.The labeling was reviewed and found to contain instructions regarding device usage.

• Brand Name: UNIVERSAL CLAMP 5.5MM TI
• Type of Device: ABBOTT SPINE UNIVERSAL CLAMP SYSTEM
• Manufacturer (Section D): ZIMMER SPINE; 23 parvis des chartrons; bordeaux 33080 ; FR 33080
• Manufacturer (Section G): ZIMMER SPINE; 23 parvis des chartrons; bordeaux 33080 ; FR 33080
• Manufacturer Contact: geoffrey gannon ; 310 interlocken parkway; broomfield, CO 80021 ; 3034437500
• MDR Report Key: 6124813
• MDR Text Key: 60791254
• Report Number: 3003853072-2016-00150
• Device Sequence Number: 1
• Product Code: JDQ
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: PK060009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/23/2016
• 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: SNA027-0-20055
• Device Lot Number: SEE H10
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/07/2017
• 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: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 13 YR