MAUDE Adverse Event Report: STRYKER SPINE-FRANCE UNKNOWN_SPINE_PRODUCT; PEDICLE SCREW SPINAL SYSTEM

Catalog Number UNK_SPN

Device Problems Naturally Worn (2988); No Apparent Adverse Event (3189)

Patient Problems Pain (1994); No Known Impact Or Consequence To Patient (2692)

Event Date 04/22/2015

Event Type  Injury  

Event Description

It was reported that; dr.Dykes was removing some old trio screws from a patient with the trio torque wrench.Per email correspondence; screws being removed was because the patient had pain resulting from the hardware from previous surgery.

Manufacturer Narrative

Conclusion: no further investigation for this event is possible at this time as no devices and insufficient information was received.

Event Description

It was reported that; dr.(b)(6) was removing some old trio screws from a patient with the trio torque wrench.Per email correspondence; screws being removed was because the patient had pain resulting from the hardware from previous surgery.

• Brand Name: UNKNOWN_SPINE_PRODUCT
• Type of Device: PEDICLE SCREW SPINAL SYSTEM
• 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: linford leitch ; 2 pearl court; allendale, NJ 07401 ; 2017608000
• MDR Report Key: 4783088
• MDR Text Key: 20149195
• Report Number: 0009617544-2015-00222
• Device Sequence Number: 1
• Product Code: MNI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,health professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/22/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/19/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Catalogue Number: UNK_SPN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/22/2015
• 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
• Patient Outcome(s): Required Intervention