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 Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Code Available (3191)

Event Date 06/19/2018

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.(b)(4).

Event Description

It was reported that a vertebral body fractured during surgery while installing two spinal implant devices.No further information has been provided.This is report two of two for this event.

Event Description

After rods and screws were installed, surgeon tried to use two universal clamps to the patient¿s vertebral arches.However, one of the vertebral arches was slightly cracked.Therefore, surgeon decided not to use the clamps to complete the operation.This is report two of two for this event.

Manufacturer Narrative

Udi number: (b)(4).Additional information in ethnicity, expiration date and udi number, method, results, and conclusions.The device was not returned for evaluation, so no results are available and no conclusions can be drawn.A review of the manufacturing records did not indicate 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: 7756375
• MDR Text Key: 116215329
• Report Number: 3003853072-2018-00059
• Device Sequence Number: 1
• Product Code: OWI
• Combination Product (y/n): N
• PMA/PMN Number: PK110348
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 12/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/07/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2022
• Device Catalogue Number: SN2027-0-20055
• Device Lot Number: W59827
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/17/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other