MAUDE Adverse Event Report: DEPUY SPINE INC M-M TI ROD 5.5MM X 48CM; APPLIANCE, FIXATION, SPINAL INTERLAMINAL

Model Number	175570000
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	03/13/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).A complaint investigation will be performed.The complaint product is not available for the investigation.A supplemental report is not anticipated unless the results of the complaint investigation identify a corrective action or additional relevant information.Should the product become available, a physical evaluation will be conducted and a supplemental report filed with the results.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
Breakage post-op.It was reported that the patient felt painful from (b)(6) of 2018, seated on the sofa and heard "gedeng" sound on (b)(6) 2018.After a moment, could walk slowly, but 2 days later, felt much more pain, went to hospital and it was found that the implant was broken.2nd surgery was done on (b)(6) 2018, and the broken rod removed.The 1st surgery was done on (b)(6) 2013.Now the patient is stable and left from the hospital.The broken rod was retained by patient.

• Brand Name: M-M TI ROD 5.5MM X 48CM
• Common Device Name: APPLIANCE, FIXATION, SPINAL INTERLAMINAL
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• MDR Report Key: 8413829
• Report Number: 1526439-2019-51444
• Device Sequence Number: 2327480
• Product Code: KWP
• UDI-Device Identifier: 10705034034133
• UDI-Public: (01)10705034034133
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K955348
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/22/2019

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 Model Number: 175570000
• Device Catalogue Number: 175570000
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/22/2019
• Initial Report FDA Received Date: 03/12/2019
• 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: 45 YR