MAUDE Adverse Event Report: MDT SOFAMOR DANEK PUERTO RICO MFG INFINITY OCCIPITOCERVICAL UPPER THORACIC SYSTEM

Catalog Number	G3605525
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product was not returned to the manufacturer for evaluation.Therefore, we are unable to determine the definitive cause of the reported event.Radiographic image review result: post-op x-ray for 6 level cervical thoracic fusion anterior/posterior provided.Ap and lateral view show bilateral fractures of the t1 pedicle screws.Fusion status is unknown.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Pre-operative diagnosis- cervical spondylosis with radiculopathy post-operative diagnosis- cervical spondylosis with radiculopathy procedure performed- 1) placement of bilateral cervical lateral mass screws, c3, c4, c5.2) placement of bilateral thoracic pedicle screws, t1.3) posterior/ posterolateral fusion-arthrodesis, c3-c4-c5-c6-c7-t1 (6 levels).4) use of allograft (medtronic orthoblend and medtronic grafton paste).5) use of intraoperative neural monitoring, somatosensory-evoked and motor-evoked potentials.6) use of intraoperative fluoroscopy for hardware and level verification.Partial explant- c3 and partial t1 screws, set screws and rods explanted.New c2, t2, t3, rods, and set screws implanted.It was reported that post-op, t1 screws broke while patient getting hair washed/cut and felt a pop in his neck.Hence on (b)(6) 2020, a revision surgery performed in which the broken screws removed.Patient has told the doctor to take legal action towards manufacturer for implant failure.There were no other patient complications reported as a result of this event.

• Brand Name: INFINITY OCCIPITOCERVICAL UPPER THORACIC SYSTEM
• Manufacturer (Section D): MDT SOFAMOR DANEK PUERTO RICO MFG; barrio marianna rd 909, km0.4; humacao PR 00792
• MDR Report Key: 9754536
• Report Number: 1030489-2020-00210
• Device Sequence Number: 1865895
• Product Code: KWP
• UDI-Device Identifier: 00643169530034
• UDI-Public: 00643169530034
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K163375
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/26/2020

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: G3605525
• Device Lot Number: H5531510
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/31/2020
• Initial Report FDA Received Date: 02/26/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 54 YR
• Patient Weight: 100