MAUDE Adverse Event Report: SEASPINE, INC HOLLYWOOD NM IMPLANT, 11MMX27MMX11MM, LORDOTIC; HOLLYWOOD NANOMETALENE

Catalog Number 34-5111

Device Problems Break (1069); Inadequacy of Device Shape and/or Size (1583)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

It was reported the implant broke in half during a procedure.The sales representative reports, " in my opinion, the implant that broke in half was due to size chosen by the surgeon was too large for interbody space.He (the surgeon) chose a size that was larger than the disk space for it to go into.So when he tamps the cage in place he really had to hammer it hard to get it to go in.He broke it due to hammering too hard.The patient was not injured.".

Manufacturer Narrative

Integra has completed their internal investigation on 12/18/2015.The investigation included: methods: evaluation of actual device, review of device history records, review of complaints history.Results: a 34-5111 hollywood nm lordotic implant was returned and evaluated by the quality and product engineers on 9/2/2015 who observed the fractured part.Based on a visual inspection of the device, a multiple fracture was evident, which can potentially occur if the implant is stressed beyond the design capability which is consistent with mallet impact as reported.During the review of the dhr for 34-5111 hollywood nm lordotic implant lot m017471d, it was concluded that an (b)(4) piece lot was received and inspected with (b)(4) pieces accepted for use by engineering and marketing as documented on ncr with the conclusion that the nonconforming characteristics did not affect the safety or efficacy of the product and 3 parts were scrapped due to damage and coating inconsistency.In the past 12 months from the awareness date (8/14/2015), a total of 5 implants were broken during insertion in the available history of the part series.(b)(4).Conclusion: based on the available information, it appears the root cause of the observed failure was likely due to the fact that the device was incorrectly sized for existing anatomy which required excessive impact force during implantation.A trend analysis for the past 12 months found this failure is within the expected occurrence range; however, the failure trend may have increased.Additionally, the risk severity associated with this failure is serious.Even though this event does not indicate a design or manufacturing defect a capa has been initiated in relation to this and other reports of implant breakage to determine root cause related to the overall trend.

• Brand Name: HOLLYWOOD NM IMPLANT, 11MMX27MMX11MM, LORDOTIC
• Type of Device: HOLLYWOOD NANOMETALENE
• Manufacturer (Section D): SEASPINE, INC; 2302 la mirada dr.; 2302 la mirada dr.; vista CA 92084
• Manufacturer (Section G): SEASPINE, INC; 2302 la mirada dr.; vista CA 92084
• Manufacturer Contact: maria leonard ; 311 enterprise drive; 311 enterprise drive; plainsboro, NJ 08536 ; 6099362393
• MDR Report Key: 5068124
• MDR Text Key: 26013086
• Report Number: 2032593-2015-00017
• Device Sequence Number: 1
• Product Code: MAX
• Combination Product (y/n): N
• PMA/PMN Number: K102026
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Other
• Type of Report: Followup
• Report Date: 08/14/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/10/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 34-5111
• Device Lot Number: M017471D
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/15/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/18/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/18/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1