MAUDE Adverse Event Report: DEPUY SPINE INC M-M 5.5 INNER SCREW, TI; APPLIANCE, FIXATION, SPINAL INTERLAMINAL

Model Number	175526000
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
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's indication is lumbar spinal stenosis, cauda equina syndrome.Did the operation of l4/s1mm, internal fixation, laminectomy on (b)(6) 2005 in (b)(6) hospital of (b)(6) university.The patient left from hospital on (b)(6) 2005.The patient felt painful and checked in (b)(6) people's hospital, noted screw and node were broken.Now the patient rejects to do 2nd surgery and sued hospital and j&j.This complaint involves three (3) devices.

• Brand Name: M-M 5.5 INNER SCREW, TI
• Common Device Name: APPLIANCE, FIXATION, SPINAL INTERLAMINAL
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• MDR Report Key: 8848057
• Report Number: 1526439-2019-51909
• Device Sequence Number: 16206718
• Product Code: KWP
• UDI-Device Identifier: 10705034033488
• UDI-Public: (01)10705034033488
• 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: 2005
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/10/2019

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: 175526000
• Device Catalogue Number: 175526000
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/10/2019
• Initial Report FDA Received Date: 07/31/2019
• 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