MAUDE Adverse Event Report: STRYKER ORTHOBIOLOGICS-MALVERN MEDPOR TITAN OFW - MTB - LEFT; IMPLANT

Catalog Number 81031

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Failure of Implant (1924)

Event Date 08/31/2017

Event Type  Injury  

Manufacturer Narrative

Device is not available for evaluation.If additional information is received it will be reported on a supplemental report.Device is implanted.

Event Description

A company representative reported that a patient had to undergo a revision surgery in order to correct maxillary alignment of a medpor titan implant.

Manufacturer Narrative

The observation stated in the reported event (maxilla malocclusion and non-ideal position of the medpor implant) could be confirmed based on the case report of the virtual surgical planning (vsp).To gain a better insight in the event and the conditions the product had been exposed to, the sales rep was contacted.It was stated that the lot number of the screws and of the medpor implant are unknown.Furthermore, no x-ray images or surgical protocols of the original surgery are available.As part of the dhr review the available information on the complaint is by default forwarded to the manufacturing site stryker orthobiologics in (b)(4) (usa) to review the related quality and manufacturing documents.As for this complaint the lot code # was not provided, a dhr review could not be performed.Additionally the vice president of concept development for medpor implants was contacted to assess this case.It was stated that the maxilla malocclusion is most probably the result of poor implant positioning during original surgery.Based on the case report of the virtual surgical planning (vsp), the original fracture doesn¿t look like a true le fort fracture where the maxilla is separated from the zygomes on both sides.It resembles rather an orbito-zygomatic fracture where the left zygoma is fractured at the superior lateral orbit, the zygomatic arch and near the maxillary zygomatic suture inferiorly.This type of fracture is difficult to reduce properly and an exact alignment of the dislocated zygoma bone fragment is hard to achieve, especially in an acute trauma setting.Thus it appears that repositioning of the bone fragment and plating it into place may have moved the maxilla slightly during original surgery, resulting in the malocclusion of the teeth.Furthermore, based on the preoperative situation illustrated in the vsp case report, it appears that the medial part of the medpor implant is positioned more laterally than it should be.It is located a little more toward the inside of the orbit than the normal position of the medial wall.It seems highly probable that during the initial trauma reconstruction surgery the medpor implant was placed in that position and this non ideal position was just not apparent.Observation of the position of the eye after the swelling resolved and also the postoperative ct scan after the original surgery probably indicated that the position of the medial part of the implant needs to be corrected additionally to the maxilla malocclusion.Simply repositioning the medial part of the implant without cutting it away from the orbital floor part would have been very difficult, because the orbital floor part appears to be correctly positioned.Thus it was easier to remove the medial implant part and reimplant only this part.In summary it can be concluded that the revision surgery was done to correct on the one hand the position of the medial part of the medpor implant and on the other hand the maxillary malocclusion.The root cause in both cases can be attributed most probably to a poor surgical technique in terms of implant positioning.Based on the investigation, the review of the vsp case report as well as the assessment of the vice president of concept development for medpor implants, there is no indication for a not correctly working product or any design, material or manufacturing related issue.Therefore no corrective and/or preventive actions are deemed necessary at that time.The complaint is added to the complaint trend.

Event Description

A company representative reported that a patient had to undergo a revision surgery in order to correct maxillary alignment of a medpor titan implant.

• Brand Name: MEDPOR TITAN OFW - MTB - LEFT
• Type of Device: IMPLANT
• Manufacturer (Section D): STRYKER ORTHOBIOLOGICS-MALVERN; 45 great valley parkway; malvern PA 19355
• Manufacturer (Section G): STRYKER ORTHOBIOLOGICS-MALVERN; 45 great valley parkway; malvern PA 19355
• Manufacturer Contact: hans geiger ; boetzingerstr. 41; freiburg D-791-11 ; 76145120
• MDR Report Key: 6884177
• MDR Text Key: 87164977
• Report Number: 0008010177-2017-00238
• Device Sequence Number: 1
• Product Code: FTM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K040364
• 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: 03/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/21/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 81031
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/31/2017
• 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