MAUDE Adverse Event Report: STRYKER LEIBINGER FREIBURG PRIMARY HEMI MANDIBULAR RECONSTRUCTION PLATE, LEFT, 5+17-HOLES, WITH TEMPLATE; IMPLANT

Model Number	55-15922
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Pain (1994)
Date of Event	10/29/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device is not available for evaluation.If additional information is received it will be reported on a supplemental report.The product was discarded by the facility at their location.
Event or Problem Description
It was reported that a reconstruction plate fracture was found post-operatively approximately two years after implantation.The procedure involved a modification of patient's dental joint with a laterodeviation of the left mandible, slight pain, especially in the right temporomandibular joint.There was no reported notion of trauma or oral closing force.
Additional Manufacturer Narrative
The reported event could not be confirmed as the device was not returned for investigation nor have images of the reported plate breakage been provided.Several requests for further information (e.G.Op report at the time of initial implantation, x-rays at the time of initial implantation, as well as, during the time the broken plate was discovered and whether the patient has received perioperative radiation) have been sent to the customer regarding the event.In the provided op report during initial implantation, it is noted that there has been a resection or removal of the mandible at the surgical site.Further, it was not mentioned that a bone graft has been used together with the reported device.However, the device under complaint is color-coded gold and is intended to be used for primary reconstructions.In the related instructions for use (ifu ¿ 90-01939 rev.8), the following is stated: ¿(¿) 2.Contraindications (¿) - secondary reconstructions with universal primary recon plates (gold colored).(¿) plate warnings and precautions (¿) - primary reconstruction (gold color) plates are not intended for use in secondary reconstruction applications.Use of such may result in excessive plate loading and premature failure.(¿)¿ it is also stated in the related brochure (leibinger universal 2, 9410-400-184, 2011) that primary recon plates (color-coded gold) are for the following indications: ¿1.For the fixation of microvascular grafts only (eg.Fibula, radius, scapula, iliac crest) in a single-step reconstruction after resection of a tumor, osteomyelitis or osteonecrosis.2.For the internal fixation of comminuted mandibular fractures.¿ after reviewing the documents provided by the customer, it could be assumed that the device has been used for secondary reconstruction (no bone graft was used together with the plate).Conclusively, the root cause of the postoperative plate breakage can be attributed to an off-label use.No lot number was provided, and a review of the specific manufacturing batch record and related quality documents (manufacturing documents, inspection plan, inspection drawing, and release report) cannot be performed.Therefore, it is also not possible to determine the quantity released for distribution within the affected lot.However, the conducted investigation steps and the provided information demonstrate much evidence that the event is not related to a manufacturing issue.Based on statistical evaluation there is no indication for an incorrectly working product or any systematic design, material, or manufacturing-related issue.Therefore, no further corrective and/or preventive actions are deemed necessary at this time.The complaint is added to the complaint trend.
Event or Problem Description
It was reported that a reconstruction plate fracture was found post-operatively approximately two years after implantation.The procedure involved a modification of patient's dental joint with a laterodeviation of the left mandible, slight pain, especially in the right temporomandibular joint.There was no reported notion of trauma or oral closing force.

• Brand Name: PRIMARY HEMI MANDIBULAR RECONSTRUCTION PLATE, LEFT, 5+17-HOLES, WITH TEMPLATE
• Common Device Name: IMPLANT
• Manufacturer (Section D): STRYKER LEIBINGER FREIBURG; boetzingerstr. 41; freiburg D-791 11; DE D-79111
• MDR Report Key: 9426289
• Report Number: 0008010177-2019-00075
• Device Sequence Number: 13992873
• Product Code: JEY
• UDI-Device Identifier: 04546540356406
• UDI-Public: 04546540356406
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K014263
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 02/04/2020

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
• Operator of Device: Health Professional
• Device Model Number: 55-15922
• Device Catalogue Number: 55-15922
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/12/2019
• Supplement Date Received by Manufacturer: 11/12/2019
• Initial Report FDA Received Date: 12/06/2019
• Supplement Report FDA Received Date: 02/04/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 67 YR
• Patient Weight: 81