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GRAFTON® DBM T44150INTRecalls & reported problems

Medtronic Sofamor Danek, Inc. · DBM T44150INT 10CC GRAFTON ORTHOBLEND SM · Class 2 · Implant

All models of GRAFTON DBM (11)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.

Adverse event reports
1
Deaths reported
0
Injuries reported
1
Recalls naming it
1

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00643169965089), received between Jun 25, 2020 and Jun 25, 2020 — classified as 1 injury.

1 FDA recall record name this device's identifier, 1 still open.

29 other recalls cover devices cleared under the same FDA submission (K051195); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

  1. Feb 8, 2023Class IIOpen, Classified

    Potential for packaging non-conformances directly related to the dual-barrier, sterile pouch packaging system. Non-conforming packaging may lead to a breach in the sterile barrier.

    Z-1326-2023 · Root cause: Process control · Recall details · FDA record ↗

Most reported problems

Device problems

  • Adverse Event Without Identified Device or Use Problem1

Patient problems

  • Fever1
  • Inflammation1
  • Unspecified Infection1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • InjuryJun 25, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT THE PATIENT PRESENTED WITH MAXILLARY CYST; AND UNDERWENT RESECTION AND CURETTAGE OF BENIGN UPPER JAW INJURY AND MAXILLARY BONE BIOPSY. THE GRAFT WAS PLACED ON THE UPPER JAW. ALLEGEDLY, ON AN UNKNOWN DATE, POST-OP, THE PATIENT HAD AN INFECTION AT THE TREATED SITE. THE SYMPTOMS OF THE INFECTION INCLUDED FEVER, INFLAMMATION OF THE AREA AND EXPULSION OF LIQUID THROUGH THE WOUND IN THE ORAL MUCOSA. ANTIBIOTIC TREATMENT WAS CARRIED OUT DUE TO THIS EVENT. ACCORDING TO THE SURGEON, THE INFECTION WAS CAUSED BY POOR ORAL HYGIENE OF THE PATIENT. HENCE, IT WAS RECOMMENDED TO WASH THE AREA WITH ORAL ANTISEPTIC TO DECREASE SYMPTOMS AND SIGNS OF INFECTION.

    Patient problems: Fever; Inflammation; Unspecified Infection

    MAUDE report 10196836 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K051195. One submission often covers many models, so check the product and lot details in each record.

  • Z-0138-2027 · Aug 12, 2026 · Open, Classified
    Grafton" DBM and Grafton Plus" DBM contain demineralized human bone tissue combined with an inert additive to yield a demineralized bone matrix (DBM) allograft product having a par
  • Z-0161-2024 · Sep 26, 2023 · Open, Classified
    Grafton DBM Crunch, Model Numbers: T44115, Demineralized Bone Matrix
  • Z-0164-2024 · Sep 26, 2023 · Open, Classified
    Grafton DBM Matrix Strips, Model Numbers: a) T42275, b) T42280; Demineralized Bone Matrix
  • Z-0167-2024 · Sep 26, 2023 · Open, Classified
    Grafton DBM Putty, Model Numbers: a) T43102, b) T43102INT, c) T43103INT, d) T43105, e) T43105INT, f) T43110, g) T43110INT; Demineralized Bone Matrix
  • Z-0165-2024 · Sep 26, 2023 · Open, Classified
    Grafton DBM Orthoblend, Model Numbers: a) T44125INT, b) T44135, c) T44145, d) T44150; Demineralized Bone Matrix
  • Z-0163-2024 · Sep 26, 2023 · Open, Classified
    Grafton DMB Matrix, Model Numbers: a) T42200, b) T42210; Demineralized Bone Matrix
  • Z-0162-2024 · Sep 26, 2023 · Open, Classified
    Grafton DBM (Flex), Model Numbers: T42100, Demineralized Bone Matrix
  • Z-0166-2024 · Sep 26, 2023 · Open, Classified
    Grafton Plus DBM Paste, Model Numbers: a) T45001, b) T45005, c) T45010; Demineralized Bone Matrix
  • Z-1327-2023 · Feb 8, 2023 · Open, Classified
    Medtronic Grafton Matrix: a) DBM S42200 GRAFTON 2.5CMX10CM 2EA MATRIX, REF S42200; b) DBM S42210 GRAFTON 2.5CMX5CM 2EA MATRIX, REF S42210; c) DBM T42200 2.5CMX10CM 2 EACH GRAFTON
  • Z-1333-2023 · Feb 8, 2023 · Open, Classified
    Medtronic Grafton Gel: a) DBM S41120 GRAFTON GEL 1CC, REF S41120; b) DBM S41150 GRAFTON GEL 10CC, REF S41150; c) DBM T41110 0.5CC GRAFTON GEL, REF T41110; d) DBM T41110INT
  • Z-1325-2023 · Feb 8, 2023 · Open, Classified
    Medtronic Grafton Flex: a) DBM S42090 GRAFTON 1.5CM X 1.5CM FLEX, REF S42090; b) DBM T42090 1.5CMX1.5CM FLEX GRAFTON, REF T42090; c) DBM T42090INT 1.5CMX1.5CM FLEX GRAFTON, REF T
  • Z-1324-2023 · Feb 8, 2023 · Open, Classified
    Medtronic Grafton Crunch a) DBM S44105 GRAFTON 5CC CRUNCH, REF S44105; b) DBM S44115 GRAFTON 15CC CRUNCH, REF S44115; c) DBM T44105 5CC GRAFTON CRUNCH, REF T44105; d) DBM T4410
  • Z-1328-2023 · Feb 8, 2023 · Open, Classified
    Medtronic Grafton Matrix Strips: a) DBM S42275 8MMX1CMX10CM 2EA MATRIX STRPS, REF S42275; b) DBM S42280 8MMX1CMX20CM 2EA MATRX STRPS, REF S42280; c) DBM T42275 8MMX1CMX10CM 2 E
  • Z-1323-2023 · Feb 8, 2023 · Open, Classified
    Medtronic Grafton Putty: a) DBM S43101 GRAFTON 0.5CC PUTTY, REF S43101; b) DBM S43102 GRAFTON 1CC PUTTY, REF S43102; c) DBM S43103 GRAFTON 2.5CC PUTTY, REF S43103; d) DBM S
  • Z-0977-2014 · Jan 6, 2014 · Terminated
    Medtronic GRAFTON (R) DBM, Flex 2.5cm x 10cm, REF T42100, Rx only, STERILE A, QTY: 1 EA, Medtronic Sofamor Danek, USA, Inc., 1800 Pyramid Place, Memphis, TN 38132 Orthopaedic - f

…and 14 more.

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Sources and updates

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