MAUDE Adverse Event Report: STRYKER GMBH OSTEOSET BONE GRAFT SUBSTITUTE 4.8MM 5CC; FILLER, BONE VOID, CALCIUM COMPOUND

Catalog Number	84000104
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bacterial Infection (1735)
Date of Event	11/17/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information has been requested and if received, will be provided in the supplemental report.
Event or Problem Description
As reported: "the patient was admitted to the hospital due to "pain in the left heel caused by a fall and inability to stand for 3 hours".Physical examination: swelling of the left heel and ankle, obvious tenderness in the heel and lateral malleolus, acceptable flexion and extension of the ankle joint, normal muscle strength and muscle tone in the distal limb, normal blood supply to the extremities, and no obvious abnormalities in sensation at the extremities.Auxiliary examination: (b)(6) 2025: x-ray: multiple fractures of the left calcaneus, and the distal end of the left lateral malleolus is irregular.The diagnosis results: multiple fractures of the left calcaneus and hypertension.Diagnosis and treatment process after the patient was admitted to the hospital, relevant examinations and tests were completed.Symptomatic treatment such as pain relief, swelling reduction and thrombosis prevention was provided to the patient.After the swelling subsided, an open reduction and bone grafting internal fixation surgery for the left calcaneal fracture was performed under intravenous anesthesia on (b)(6) 2025.During the operation, bone graft replacement materials were used to fill the bone defect area.The anesthesia was satisfactory and the operation went smoothly.The patient was safely returned to the ward after the operation.Symptomatic treatments such as reducing swelling, relieving pain and preventing infection were given, and the healing of the incision was observed.During the hospital stay, the condition was stable.Postoperative x-ray reexamination showed that the fracture was well reduced and the internal fixator was in place.Eleven days after the operation, a sudden purulent and bloody exudate with sediment drainage occurred at the wound site.Vsd negative pressure sealing drainage was placed.Re-examination of blood routine, crp, and procalcitonin showed no significant increase.Bacterial culture indicated staphylococcus epidermidis contamination.Four days later, after the negative pressure device was removed, there was still purulent and bloody exudate.Wound dressing change and anti-infection treatment were given.On (b)(6), the left heel was debrided under nerve block anesthesia again, with antibiotic bone cement placed and vsd negative pressure sealing drainage performed.During the operation, bone graft materials were removed and vancomycin bone cement was filled and covered at the defect site.One week after the operation, the negative pressure sealing drainage device was removed and debridement and suture were carried out.After the operation, continue symptomatic treatment such as anti-infection and improvement of microcirculation, observe the healing of the wound, and remove the stitches two weeks later.".
Event or Problem Description
As reported: "the patient was admitted to the hospital due to "pain in the left heel caused by a fall and inability to stand for 3 hours".Physical examination: swelling of the left heel and ankle, obvious tenderness in the heel and lateral malleolus, acceptable flexion and extension of the ankle joint, normal muscle strength and muscle tone in the distal limb, normal blood supply to the extremities, and no obvious abnormalities in sensation at the extremities.Auxiliary examination: (b)(6) 2025 x-ray: multiple fractures of the left calcaneus, and the distal end of the left lateral malleolus is irregular.The diagnosis results: 1.Multiple fractures of the left calcaneus.2.Hypertension diagnosis and treatment process after the patient was admitted to the hospital, relevant examinations and tests were completed.Symptomatic treatment such as pain relief, swelling reduction and thrombosis prevention was provided to the patient.After the swelling subsided, an open reduction and bone grafting internal fixation surgery for the left calcaneal fracture was performed under intravenous anesthesia on (b)(6) 2025.During the operation, bone graft replacement materials were used to fill the bone defect area.The anesthesia was satisfactory and the operation went smoothly.The patient was safely returned to the ward after the operation.Symptomatic treatments such as reducing swelling, relieving pain and preventing infection were given, and the healing of the incision was observed.During the hospital stay, the condition was stable.Postoperative x-ray reexamination showed that the fracture was well reduced and the internal fixator was in place.Eleven days after the operation, a sudden purulent and bloody exudate with sediment drainage occurred at the wound site.Vsd negative pressure sealing drainage was placed.Re-examination of blood routine, crp, and procalcitonin showed no significant increase.Bacterial culture indicated staphylococcus epidermidis contamination.Four days later, after the negative pressure device was removed, there was still purulent and bloody exudate.Wound dressing change and anti-infection treatment were given.On (b)(6), the left heel was debrided under nerve block anesthesia again, with antibiotic bone cement placed and vsd negative pressure sealing drainage performed.During the operation, bone graft materials were removed and vancomycin bone cement was filled and covered at the defect site.One week after the operation, the negative pressure sealing drainage device was removed and debridement and suture were carried out.After the operation, continue symptomatic treatment such as anti-infection and improvement of microcirculation, observe the healing of the wound, and remove the stitches two weeks later.".
Additional Manufacturer Narrative
The reported event could be confirmed based on assessment of available information and x-rays.The device inspection was not possible as the product was not returned for investigation.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.No indications of material, manufacturing or design related problems were found during the investigation.A review of the labeling did not indicate any abnormalities.Microbiologist reviewed the sterilization procedures, environmental monitoring, bioburden data and the dhr and noted: the subject device was packaged according to established design and process specifications, and was sterilized according to procedure.No deviation for a non-conformance could be found.Upon review of provided x-rays medical expert opined that: infections are multifactorial events.They are not uncommon in calcaneal fracture surgery (orif).In this case contamination of the surgical site by patient¿s skin bacteria was the case.Based on investigation, the root cause was attributed most likely to a patient-related issue.The event was caused by contamination of surgical site by patients skin bacteria which eventually resulted in infection.If device is returned or any further information is provided, the investigation report will be reassessed.

• Brand Name: OSTEOSET BONE GRAFT SUBSTITUTE 4.8MM 5CC
• Common Device Name: FILLER, BONE VOID, CALCIUM COMPOUND
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach TN 2545 ; SZ 2545
• Manufacturer (Section G): WRIGHT MEDICAL TECHNOLOGY, INC.; 11576 memphis arlington rd; arlington TN 38002
• Manufacturer Contact: dannielle stap ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 24121853
• Report Number: 3010667733-2026-00058
• Device Sequence Number: 17661301
• Product Code: MQV
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K963562
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: User Facility
• Type of Report: Initial,Followup
• Report Date (Section B): 05/13/2026

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?: No
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 84000104
• Device Lot Number: 1805330
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/22/2025
• Supplement Date Received by Manufacturer: 04/17/2026
• Initial Report FDA Received Date: 01/20/2026
• Supplement Report FDA Received Date: 05/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/16/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 36 YR
• Patient Sex: Female