MAUDE Adverse Event Report: ZIMMER SPINE UNIVERSAL CLAMP GENERIC

Model Number SN2027 UNIVERSAL

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Granuloma (1876); Reaction (2414)

Event Type  Injury  

Event Description

Same case as: 3003863072-2014-00036.Info received from journal article.Pt underwent surgery then experienced implant-related complications with developments of an aseptic soft tissue reaction with granulomas adjacent to the sublaminar polyethylene terephthalate strapsetitanium clamp mechanism of the device 8 months after ais correction surgery.

• Brand Name: UNIVERSAL CLAMP GENERIC
• Type of Device: UNIVERSAL CLAMP GENERIC
• Manufacturer (Section D): ZIMMER SPINE; cite mondiale; 23 parvis des chartrons; bordeaux 3308 0; FR 33080
• Manufacturer Contact: scott lapointe ; 7375 bush lake rd.; minneapolis, MN 55439 ; 9528325600
• MDR Report Key: 4234419
• MDR Text Key: 15366438
• Report Number: 3003853072-2014-00035
• Device Sequence Number: 1
• Product Code: JDQ
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 10/05/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/31/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SN2027 UNIVERSAL
• Device Catalogue Number: SN2027 UNIVERSAL
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/05/2014
• 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
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention