MAUDE Adverse Event Report: BIOMET SPAIN, S.L. NEOCIF INSERTION INSTRUMENT; SPINAL VERTEBRAL BODY REPLACEMENT DEVICE

Model Number N/A

Device Problem Device Markings/Labelling Problem (2911)

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

Event Date 06/20/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).This product is manufactured by zimmer biomet (b)(4) and is not cleared or distributed in the u.S.However, this report is being submitted as zimmer biomet (b)(4) manufactures a similar device that is cleared or distributed in the united states under 510(k) number k092336.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that the markings on the insertion instrument are not readable and in the wrong location.It was reported that during the procedures in which the instrument was used, the cages may have been implanted 180° inverted due to the markings.No patient injury has been reported.

• Brand Name: NEOCIF INSERTION INSTRUMENT
• Type of Device: SPINAL VERTEBRAL BODY REPLACEMENT DEVICE
• Manufacturer (Section D): BIOMET SPAIN, S.L.; calle islas baleares, #50; p.o. box 96; fuente del jarro, valencia 46988 ; SP 46988
• Manufacturer (Section G): BIOMET SPAIN, S.L.; calle islas baleares, #50; p.o. box 96; fuente del jarro, valencia 46988 ; SP 46988
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 6728974
• MDR Text Key: 80700790
• Report Number: 0009610576-2017-00028
• Device Sequence Number: 1
• Product Code: MQP
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: PSEE H10
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: N/A
• Device Catalogue Number: 2263-00
• Device Lot Number: 54501170
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/27/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/20/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/06/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1