MAUDE Adverse Event Report: ZIMMER SPINE SPINAL IMPLANT FOR OSTEOSYNTHESIS (TI) DIAMETER 5.5MM; UNIVERSAL CLAMP SPINAL FIXATION SYSTEM

Catalog Number SN2027-0-20055

Device Problems Break (1069); Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problem No Code Available (3191)

Event Date 12/14/2018

Event Type  Injury  

Manufacturer Narrative

Udi number: ni.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.Reference report 3003853072-2019-00001.

Event Description

It was reported that a revision surgery was performed to address post-operative loosening of the construct.During the revision, the nylon band broke.This is report two of two for this event.

Event Description

It was reported that a revision surgery was performed to address post-operative loosening of the construct.During the revision, the nylon band broke.This is report two of two for this event.

Manufacturer Narrative

Udi number: (b)(4).Additional information in expiration date and udi number, and method, results, and conclusions codes.The device was not returned, but a photo of the device provided by the reporter was used for evaluation.The band was found to have broken.The cause is likely attributed to unintentional use error.A review of the dhr did not identify any issues which would have contributed to this event.The labeling was reviewed and found to contain instructions regarding proper device usage.

Event Description

T was reported that a revision surgery was performed to address post-operative loosening of the construct.During the revision, the nylon band broke.This is report two of two for this event.

Manufacturer Narrative

Additional information in concomitant medical products and method and results codes.Visual inspection revealed that, as reported, the band is broken.The u-clamp device was not returned, however, it can be seen from the provided x-rays that it has loosened from its intended position.The cause can likely be attributed to unintentional use error.A review of the dhr did not identify any issues which would have contributed to this event.The labeling was reviewed and found to contain instructions regarding proper device usage.

• Brand Name: SPINAL IMPLANT FOR OSTEOSYNTHESIS (TI) DIAMETER 5.5MM
• Type of Device: UNIVERSAL CLAMP SPINAL FIXATION SYSTEM
• Manufacturer (Section D): ZIMMER SPINE; 23 parvis des chartrons; cite mondiale; bordeaux, cedex 33080 ; FR 33080
• MDR Report Key: 8226409
• MDR Text Key: 132365952
• Report Number: 3003853072-2019-00002
• Device Sequence Number: 1
• Product Code: OWI
• Combination Product (y/n): N
• PMA/PMN Number: K110348
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 11/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/20/2023
• Device Catalogue Number: SN2027-0-20055
• Device Lot Number: W62483
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/17/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention