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

Model Number	165-001
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Unspecified Musculoskeletal problem (4535)
Type of Reportable Event	Serious Injury
Additional 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 or Problem Description
It was reported that two centerline modular heads came off of the screws during surgery.

• Brand Name: CENTERLINE MODULAR
• Common Device Name: 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
• Report Number: 3004499989-2022-00008
• Device Sequence Number: 12231568
• Product Code: NKB
• UDI-Device Identifier: 00190837076436
• UDI-Public: (01)00190837076436(10)JI76
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K183430
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: 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
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/26/2022
• Initial Report FDA Received Date: 06/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/21/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown