MAUDE Adverse Event Report: STRYKER SPINE-FRANCE DIAPASON ROD 480 MM; SPINAL INTERLAMINAL FIXATION ORTHOSIS

Catalog Number	665480
Medical Device Problem Codes	Fracture (1260); Material Integrity Problem (2978)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994)
Date of Event	08/25/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that; "patient underwent surgery on (b)(6) 2009 where she was implanted with spinal system, including the rod.The rod was placed on either side of the patient's spine between l3 and s1.Records of the surgical procedure are attached.On (b)(6) 2016, following years of continued lower back pain, the patient underwent a lumbar spine ct scan that showed the titanium rods are broken at the l5 level.".
Additional Manufacturer Narrative
Method: risk assessment; device history review, device evaluation and complaint history review could not be performed as no items were returned.The event could not be confirmed nor the root cause of the reported event determined because no device and/or insufficient information was provided for review.
Event or Problem Description
It was reported that; "patient underwent surgery on (b)(6) 2009 where she was implanted with spinal system, including the rod.The rod was placed on either side of the patient's spine between l3 and s1.On (b)(6) 2016, following years of continued lower back pain, the patient underwent a lumbar spine ct scan that showed the titanium rods are broken at the l5 level.".

• Brand Name: DIAPASON ROD 480 MM
• Common Device Name: SPINAL INTERLAMINAL FIXATION ORTHOSIS
• Manufacturer (Section D): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• MDR Report Key: 6301342
• Report Number: 0009617544-2017-00046
• Device Sequence Number: 1102651
• Product Code: KWP
• UDI-Device Identifier: 04546540383587
• UDI-Public: (01)04546540383587
• Combination Product (Y/N): N
• Initial Reporter State: AK
• Initial Reporter Country: US
• PMA/510(K) Number: K0951725
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/04/2017

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: No Information
• Device Catalogue Number: 665480
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 01/10/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/03/2017
• Supplement Report FDA Received Date: 04/04/2017
• 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: Other
• Patient Age: 66 YR