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	12/11/2018
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
Postoperative rod breakage.It was reported that patient accepted scoliosis correction and internal fixation on (b)(6) 2016.No abnormality was observed during procedure.2 years later, the patient was uncomfortable and returned hospital.It was found rod broke on (b)(6), 2018.The broken one was removed and revision surgery was operated on (b)(6), 2019.Then patient condition changed better.No further information could be provided.
Additional Manufacturer Narrative
Product complaint # = > (b)(4).The moss miami ti 5.5x480mm rod was not returned to the complaint handling unit (chu).The device is noted as having been discarded after the revision procedure was completed.A review of the device history record did not find any issues that may have caused or contributed to the reported event.The rod was released accomplishing all quality requirements.All complaint trends will be evaluated as a part of the depuy spine monthly complaint review meeting.Without the rod, we are unable to confirm the reported issue or identify the root cause.As no issues could be identified in the manufacturing or release of this product, this complaint will be closed with no further action required.If more information and/or the complaint sample become available at a later date, the complaint will be reopened and the product will be evaluated.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• 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: 8595463
• Report Number: 1526439-2019-51626
• Device Sequence Number: 2191743
• 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: 2016
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/17/2019

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
• Device Lot Number: 10BDJD1TK
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/17/2019
• Supplement Date Received by Manufacturer: 07/09/2019
• Initial Report FDA Received Date: 05/09/2019
• Supplement Report FDA Received Date: 07/10/2019
• 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