MAUDE Adverse Event Report: STRYKER SPINE-FRANCE UNKNOWN_SPINE_PRODUCT

Catalog Number UNK_SPN

Device Problems Loose or Intermittent Connection (1371); Mechanical Problem (1384); Migration or Expulsion of Device (1395)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Information (3190)

Event Date 10/17/2017

Event Type  malfunction  

Event Description

It was reported that: "today, i did a revision due to a flarehawk issue.He has to loosen the 4.5 construct and commented on how loose the blocker was when removing.He was concerned.¿.

Event Description

It was reported that: "today, i did a revision due to a flarehawk issue.He has to loosen the 4.5 construct and commented on how loose the blocker was when removing.He was concerned.¿.

• Brand Name: UNKNOWN_SPINE_PRODUCT
• Type of Device: UNKNOWN_SPINE_PRODUCT
• Manufacturer (Section D): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• Manufacturer (Section G): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• Manufacturer Contact: christa marrow ; 2 pearl court; allendale, NJ 07401 ; 2017608000
• MDR Report Key: 7033241
• MDR Text Key: 92846072
• Report Number: 0009617544-2017-00407
• Device Sequence Number: 1
• Product Code: MAX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: UNK_SPN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/18/2017
• Initial Date FDA Received: 11/15/2017
• Supplement Dates Manufacturer Received: 10/18/2017
• Supplement Dates FDA Received: 01/19/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1