MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH MD VIT SLV AND 2.0MM HOMOG CBL; CERCLAGE, FIXATION

Catalog Number	6704-0-510
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	02/22/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Review of the product history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.There has been no other events reported.It was noted that the device is not available for evaluation.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.Not returned.
Event or Problem Description
Following a review of the provided implant sheets it was identified that an infection event had taken place in 2017.
Additional Manufacturer Narrative
The following devices were also listed in this report: md vit slv and 2.0mm homog cbl; cat# 6704-0-510; lot# 49279101 md vit slv and 2.0mm homog cbl; cat# 6704-0-510; lot# 50133901 md vit slv and 2.0mm homog cbl; cat# 6704-0-510; lot# 50201002 md vit slv and 2.0mm homog cbl; cat# 6704-0-510; lot# 50133911 md vit slv and 2.0mm homog cbl; cat# 6704-0-510; lot# 50201002 md vit slv and 2.0mm homog cbl; cat# 6704-0-510; lot# 50133901 md vit slv and 2.0mm homog cbl; cat# 6704-0-510; lot# 50133901 it cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.An event regarding infection involving a dall miles cable was reported.The event was not confirmed.Method & results: -device evaluation and results: not performed as the device was not returned for evaluation.-medical records received and evaluation: no information was received for review with the clinical consultant.-device history review: all devices in the reported lot were manufactured and accepted into final stock with no relevant reported discrepancies.-complaint history review: there have been no other similar events for the reported lot or for the reported sterile lot.Conclusions: the exact cause of the event could not be determined because insufficient information was provided.Further information such as return of device,pathology reports, operative reports, x-rays, patient history & follow-up notes are needed to investigate this event further.If additional information and/or device become available, this investigation will be reopened.
Event or Problem Description
Following a review of the provided implant sheets it was identified that an infection event had taken place in 2017.Update: patient previously had cancer and poor bone quality.

• Brand Name: MD VIT SLV AND 2.0MM HOMOG CBL
• Common Device Name: CERCLAGE, FIXATION
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 7242707
• Report Number: 0002249697-2018-00335
• Device Sequence Number: 1223401
• Product Code: JDQ
• UDI-Device Identifier: 07613327036442
• UDI-Public: 07613327036442
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K945294
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/29/2018

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2021
• Device Catalogue Number: 6704-0-510
• Device Lot Number: 56456704
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/08/2018
• Supplement Date Received by Manufacturer: 08/01/2018
• Initial Report FDA Received Date: 02/05/2018
• Supplement Report FDA Received Date: 08/29/2018
• 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