MAUDE Adverse Event Report: STRYKER SPINE-FRANCE UNKNOWN_SPINE_PRODUCT; SPINAL INTERVERTEBRAL BODY FIXATION ORTHOSIS

Catalog Number UNK_SPN

Device Problems Break (1069); Fracture (1260); Material Integrity Problem (2978)

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

Event Date 06/19/2017

Event Type  malfunction  

Event Description

It was reported that the patient received a revision surgery for implant breakage in (b)(6) 2017.It was reported that the patient presented with implant breakage again on (b)(6) 2017.It was reported that the plate had broken in two places.It was reported that surgeon will not be revising the patient at this time.

Manufacturer Narrative

Manufacturing files were not reviewed due to no parts or lot provided.The probable root cause of this reported event is not determined.

Event Description

It was reported that; it was reported that the patient received a revision surgery for implant breakage in (b)(6) 2017.It was reported that the patient presented with implant breakage again on (b)(6) 2017.It was reported that the plate had broken in two places.It was reported that surgeon will not be revising the patient at this time.

• Brand Name: UNKNOWN_SPINE_PRODUCT
• Type of Device: SPINAL INTERVERTEBRAL BODY FIXATION ORTHOSIS
• 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: 6713679
• MDR Text Key: 80286268
• Report Number: 0009617544-2017-00280
• Device Sequence Number: 1
• Product Code: KWQ
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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: 10/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2017
• 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
• Date Manufacturer Received: 06/19/2017
• 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