MAUDE Adverse Event Report: LIFE SPINE CENTERLINE MODULAR; INTERVERTEBRAL BODY FUSION DEVICE

Model Number 165-001

Device Problem Migration (4003)

Patient Problem Unspecified Musculoskeletal problem (4535)

Event Type  Injury  

Manufacturer Narrative

It is unknown why the failure was caused either surgeon technique, patient post-operative activise could have reported to the event.The failure of the tulip head was flared out and peeled where the bone screw's spherical head were forced through the taper lock.

Event Description

It was reported that two centerline modular heads came off of the screws during surgery.

• Brand Name: CENTERLINE MODULAR
• Type of Device: INTERVERTEBRAL BODY FUSION DEVICE
• Manufacturer (Section D): LIFE SPINE; 13951 south quality drive; huntley IL 60142
• Manufacturer (Section G): LIFE SPINE; 13951 south quality drive; huntley IL 60142
• Manufacturer Contact: angela batker ; 13951 south quality drive; huntley, IL 60142 ; 8478846117
• MDR Report Key: 14788981
• MDR Text Key: 295050888
• Report Number: 3004499989-2022-00008
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 00190837076436
• UDI-Public: (01)00190837076436(10)JI76
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K183430
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/23/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 165-001
• Device Catalogue Number: 165-001
• Device Lot Number: JI76
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/26/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/26/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/21/2020
• 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