MAUDE Adverse Event Report: BIOMET SPAIN, S.L. UNKNOWN ORTHOSIS; SPINAL PEDICAL FIXATION

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problems Nerve Damage (1979); Pain (1994); Ambulation Difficulties (2544)

Event Type  Injury  

Manufacturer Narrative

This user facility is outside of the united states.The product identification necessary to review manufacturing history was not provided.Current information is insufficient to permit a conclusion as to the cause of the event.This device is not cleared for distribution in the u.S.; however, a similar device is cleared in the u.S.Under 510k number k031354.This report is based on allegations set forth in patient's complaint and the allegations contained therein are unverified.

Event Description

Patient underwent spinal arthrodesis procedure.Subsequently, patient alleges undergoing an unspecified reoperation procedure approximately 4 years post-implantation due to lower back problems and ambulation difficulties with permanent nerve damage occurring approximately 3 years post-op.This report is based on allegations set forth in patient's complaint and the allegations contained therein are unverified.

• Brand Name: UNKNOWN ORTHOSIS
• Type of Device: SPINAL PEDICAL FIXATION
• 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: 6231413
• MDR Text Key: 64121830
• Report Number: 0009610576-2017-00003
• Device Sequence Number: 1
• Product Code: MNI
• Combination Product (y/n): N
• Reporter Country Code: PO
• PMA/PMN Number: PK031354
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/07/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: N/A
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/07/2016
• 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): Hospitalization; Required Intervention; Disability