MAUDE Adverse Event Report: ISOTIS ORTHOBIOLOGICS INC. MOZAIK

Device Problem No Apparent Adverse Event (3189)

Patient Problem Failure of Implant (1924)

Event Date 01/27/2016

Event Type  Injury  

Manufacturer Narrative

Isotis mozaik putty, 510(k): k062353, product code: (b)(4).Isotis mozaik strip, 510(k): k063124, product code: (b)(4).Treatment description: a revision surgery occurred to replace the non-seaspine interbody.Outcome: resolved without sequela; no long term consequences as a result of the adverse event post revision surgery.Review of labeling: isotis mozaik putty intended use and indications isotis mozaik putty, combined with bone marrow aspirate, is intended for use as a bone void filler to fill voids or gaps of the skeletal system in the extremities, spine, and pelvis not intrinsic to the stability of the bony structure.Isotis mozaik putty is also indicated for use in the treatment of surgically treated osseous defects or osseous defects created from traumatic injury to the bone.Following placement in the bony void or gap (defect), isotis mozaik putty is resorbed and replaced with bone during the healing process.Description: the isotis mozaik¿ osteoconductive scaffold - putty (isotis mozaik putty) is a resorbable bone void filler made from a porous highly purified collagen matrix that has high purity tricalcium phosphate (tcp) granules dispersed throughout.The implant is provided sterile, non-pyrogenic, for single use in double peel packages.The isotis mozaik putty bone grafting construct is designed to facilitate the repair of bony defects.In the dry state, the matrix has a three dimensional trabecular network of pores that resembles the pore structure of human cancellous bone.The isotis mozaik putty quickly imbibes fluids, making it easy to combine with bone marrow aspirate.The isotis mozaik putty guides the regeneration of bone across the defect site into which the putty is implanted.New bone forms in apposition to the matrix surface when the graft is placed in direct contact with viable host bone.Ultimately the matrix is resorbed and remodeled into bone.Isotis mozaik strip intended use and indications isotis mozaik strip, combined with bone marrow aspirate (bma), is intended for use as a bone void filler to fill voids or gaps of the skeletal system in the extremities, spine, and pelvis not intrinsic to the stability of the bony structure.Isotis mozaik strip is also indicated for use in the treatment of surgically treated osseous defects or osseous defects created from traumatic injury to the bone.Following placement in the bony void or gap (defect), isotis mozaik strip is resorbed and replaced with bone during the healing process.Description: the isotis mozaik¿ osteoconductive scaffold - strip (isotis mozaik strip) is a resorbable bone void filler made from a porous highly purified collagen matrix that has high purity tricalcium phosphate (tcp) granules dispersed throughout.The implant is provided sterile, non-pyrogenic, for single use in double peel packages.The isotis mozaik strip bone grafting construct is designed to facilitate the repair of bony defects.In the dry state, the matrix has a three dimensional trabecular network of pores that resembles the pore structure of human cancellous bone.The isotis mozaik strip quickly imbibes fluids, making it easy to combine with bone marrow aspirate.The isotis mozaik strip guides the regeneration of bone across the defect site into which the strip is implanted.New bone forms in apposition to the matrix surface when the graft is placed in direct contact with viable host bone.Ultimately the matrix is resorbed and remodeled into bone.Adverse events: as with other bone grafting materials, the following complications are potential complications for isotis mozaik putty: superficial wound infection, deep wound infection, deep wound infection with osteomyelitis, nonunion, wound dehiscence, delayed union, malunion, loss of reduction, refracture, cyst recurrence, hematoma, and cellulitis.Immunological reactions consisting of transient localized edema, swelling, and rash have been reported to occur with bone void fillers containing collagen.Isotis orthobiologics, inc.Is not aware of any evidence that the device will be unsafe or ineffective in such patients, the safety and effectiveness of the device in these patients has not been established.Occurrence of one or more of these conditions may require an additional surgical procedure and may also require removal of the bone void filler.

Event Description

The patient underwent spinal surgery from levels t10-s1 on (b)(6) 2014, which consisted of a non-seaspine interbody/posterior fixation and seaspine's mozaik.It is unknown if the mozaik implanted was putty or strips.Seaspine was made aware on (b)(6) 2020 of pseudarthrosis across the l5-s1 level.

• Brand Name: MOZAIK
• Type of Device: MOZAIK
• Manufacturer (Section D): ISOTIS ORTHOBIOLOGICS INC.; 2 goodyear, suite a; irvine CA 92618
• Manufacturer (Section G): ISOTIS ORTHOBIOLOGICS INC.; 2 goodyear, suite a; irvine CA 92618
• Manufacturer Contact: audrey mudderman ; 5770 armada drive; carlsbad, CA 92008 ; 7602165137
• MDR Report Key: 11135961
• MDR Text Key: 231340249
• Report Number: 3001503333-2020-00003
• Device Sequence Number: 1
• Product Code: MQV
• 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
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/07/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/08/2020
• 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