MAUDE Adverse Event Report: MDT SOFAMOR DANEK PUERTO RICO MFG CAPSTONE PTC SPINAL SYSTEM; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT,

Model Number	3993209
Medical Device Problem Code	Break (1069)
Date of Event	02/16/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Information was received from a distributor (dis), healthcare provider (hcp) via manufacturer representative regarding a patient for unknown spinal therapy.It was reported that after inserting the implant completely, the surgeon hammered the implant inserter, and the end of implant was split.There were no fragments left inside the patient and no further complications or symptoms were reported.

• Brand Name: CAPSTONE PTC SPINAL SYSTEM
• Common Device Name: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT,
• Manufacturer (Section D): MDT SOFAMOR DANEK PUERTO RICO MFG; barrio marianna rd 909, km0.4; humacao PR 00792
• Manufacturer (Section G): MDT SOFAMOR DANEK PUERTO RICO MFG; barrio marianna rd 909, km0.4; humacao PR 00792
• Manufacturer Contact: glen belmer ; 1800 pyramid place; memphis, TN 38132 ; 6122713209
• MDR Report Key: 13768273
• Report Number: 1030489-2022-00253
• Device Sequence Number: 20081904
• Product Code: MAX
• UDI-Device Identifier: 00643169187337
• UDI-Public: 00643169187337
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K172199
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/15/2022

1 Device was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 3993209
• Device Catalogue Number: 3993209
• Device Lot Number: H5611054
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/17/2022
• Initial Report FDA Received Date: 03/15/2022
• Date Device Manufactured: 07/21/2020
• 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