MAUDE Adverse Event Report: STRYKER SPINE-FRANCE OIC PEEK SIZE 11 MM - 0DEG; INTERVERTEBRAL BODY FUSION DEVICE

Catalog Number 6731100

Device Problems Break (1069); Material Fragmentation (1261); Material Integrity Problem (2978)

Patient Problems Aspiration/Inhalation (1725); Injury (2348); No Known Impact Or Consequence To Patient (2692); Device Embedded In Tissue or Plaque (3165)

Event Date 06/26/2015

Event Type  Injury  

Event Description

It was reported that; when introducing the cage with the implant setting tool and hammer in the appropriate intervertebral disc space the cage broke apart.Thereby, the dura was injured.The rising csf was aspirated and thereby also the small fragments of cages.Cage can´t be removed and stay in situ.At the moment is unclear if a medical intervention will be necessary.Surgical delay of approx.45min.

Manufacturer Narrative

Method: device history review; complaint history review; risk assessment; results: materials analysis confirmed the cause of cage fracture to be a user applied overload during insertion.Conclusion: the plausible root cause of the reported event is user related, specifically excessive force during insertion of the implant.

Event Description

It was reported that; when introducing the cage with the implant setting tool and hammer in the appropriate intervertebral disc space the cage broke apart.Thereby, the dura was injured.The rising csf was aspirated and thereby also the small fragments of cages.Cage can't be removed and stay in situ.At the moment is unclear if a medical intervention will be necessary.Surgical delay of approx.45min.

• Brand Name: OIC PEEK SIZE 11 MM - 0DEG
• Type of Device: INTERVERTEBRAL BODY FUSION DEVICE
• 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: 4960939
• MDR Text Key: 20732269
• Report Number: 0009617544-2015-00350
• Device Sequence Number: 1
• Product Code: MAX
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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,Followup
• Report Date: 07/08/2015

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
• Device Operator: Other
• Device Catalogue Number: 6731100
• Device Lot Number: 76183
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/08/2015
• Initial Date FDA Received: 08/03/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/11/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/18/2015
• 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): Other
• Patient Age: 71 YR
• Patient Weight: 88