LCP 02.113.103Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 10886982034724), received between Feb 15, 2019 and Jul 10, 2025 — classified as 19 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Break” (1 report).

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 16, 2026.

Most reported problems

Recent adverse event reports

The 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 10, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT ON (B)(6), 2025 THE LOCKING SCREWS WOULD NOT LOCK INTO PLATE, PLATE THREADS WARPED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22469724 ↗
• InjuryJun 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS COMPLAINT IS FROM A DATA USE AGREEMENT (DUA). THE DUA SUMMARIZES 116 PATIENTS THAT WERE IMPLANTED WITH THE LCP HOOK PLATE SYSTEM 3.5MM BETWEEN OCTOBER 2015 TO FEBRUARY 2023 AT SANFORD RESEARCH. SUBJECT ID 90: A 16-YEAR-OLD MALE PATIENT WHO UNDERWENT FRACTURE FIXATION (STAGED, REMOVAL OF EX FIX AND ORIF PILON FRACTURE). POSTOPERATIVE COMPLICATIONS AND TREATMENT/INTERVENTION INCLUDE: - PAINFUL HARDWARE REQUIRING REMOVAL OF HOOK PLATE AND RIM PLATE HARDWARE. IMPLANT(S) INVOLVED: 02.113.103 X 1; CORTEX SCREWS X 2; LCP 2.4 MM RIM PLATE X 1; UNKNOWN SCREWS X 1.

  Patient problems: Pain

  MAUDE report 22131453 ↗
• InjuryMay 29, 2025Break; Break

  THIS COMPLAINT IS FROM A DATA USE AGREEMENT (DUA). THE DUA SUMMARIZES 116 PATIENTS THAT WERE IMPLANTED WITH THE LCP HOOK PLATE SYSTEM 3.5MM BETWEEN OCTOBER 2015 TO FEBRUARY 2023 AT SANFORD RESEARCH. SUBJECT ID (B)(6): AN 18-YEAR-OLD MALE PATIENT WHO UNDERWENT FRACTURE FIXATION (OPEN REDUCTION INTERNAL FIXATION RIGHT ANKLE). POSTOPERATIVE COMPLICATIONS AND TREATMENT/INTERVENTION INCLUDE: - POST-TRAUMATIC ARTHRITIS, HOOK PLATE FRACTURE POSTERIOR ASPECT AT THE 2ND HOLE FROM THE PROXIMAL SCREW REQUIRING HARDWARE REMOVAL IMPLANT(S) INVOLVED: 02.113.103. THIS COMPLAINT INVOLVES A TOTAL OF 12 IDENTIFIED PATIENTS. THIS PC IS CREATED TO CAPTURE SUBJECT ID (B)(6). THIS IS RELATED TO (B)(4).

  Patient problems: Arthritis

  MAUDE report 22106950 ↗
• InjuryMay 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS COMPLAINT IS FROM A DATA USE AGREEMENT (DUA). THE DUA SUMMARIZES 116 PATIENTS THAT WERE IMPLANTED WITH THE LCP HOOK PLATE SYSTEM 3.5MM BETWEEN OCTOBER 2015 TO FEBRUARY 2023 AT SANFORD RESEARCH. SUBJECT ID (B)(6): A 60-YEAR-OLD FEMALE PATIENT WHO UNDERWENT FRACTURE FIXATION (ORIF OF RIGHT DISTAL FIBULA). POSTOPERATIVE COMPLICATIONS AND TREATMENT/INTERVENTION INCLUDE: - PAIN D/T HARDWARE OF LEFT DISTAL FIBULA REQUIRING REMOVAL OF HOOK PLATE. IMPLANT(S) INVOLVED: 02.113.103 CORTEX SCREWS X 3. THIS COMPLAINT INVOLVES A TOTAL OF 12 IDENTIFIED PATIENTS. THIS PC IS CREATED TO CAPTURE SUBJECT ID (B)(6). THIS IS RELATED TO (B)(4).

  Patient problems: Pain

  MAUDE report 22105353 ↗
• InjuryMay 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS COMPLAINT IS FROM A DATA USE AGREEMENT (DUA). THE DUA SUMMARIZES 116 PATIENTS THAT WERE IMPLANTED WITH THE LCP HOOK PLATE SYSTEM 3.5MM BETWEEN OCTOBER 2015 TO FEBRUARY 2023 AT SANFORD RESEARCH. SUBJECT ID (B)(6): A 26-YEAR-OLD FEMALE PATIENT WHO UNDERWENT FRACTURE FIXATION (SURGICAL REDUCTION AND INTERNAL FIXATION OF RIGHT ANKLE FRACTURE, BIMALLEOLAR). POSTOPERATIVE COMPLICATIONS AND TREATMENT/INTERVENTION INCLUDE: PAINFUL HARDWARE REQUIRING HARDWARE REMOVAL IMPLANT(S) INVOLVED: 02.113.103, UNKNOWN SCREWS X 3. THIS COMPLAINT INVOLVES A TOTAL OF 12 IDENTIFIED PATIENTS. THIS PC IS CREATED TO CAPTURE SUBJECT ID (B)(6). THIS IS RELATED TO (B)(4).

  Patient problems: Pain

  MAUDE report 22104544 ↗
• InjuryMay 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS COMPLAINT IS FROM A DATA USE AGREEMENT (DUA). THE DUA SUMMARIZES 116 PATIENTS THAT WERE IMPLANTED WITH THE LCP HOOK PLATE SYSTEM 3.5MM BETWEEN (B)(6) 2015 TO (B)(6) 2023 AT SANFORD RESEARCH. SUBJECT ID (B)(6): A 74-YEAR-OLD MALE PATIENT WHO UNDERWENT FRACTURE FIXATION (OPEN REDUCTION INTERNAL FIXATION LEFT ANKLE). POSTOPERATIVE COMPLICATIONS AND TREATMENT/INTERVENTION INCLUDE: INADEQUATE FIXATION LEADING TO MALUNION, HARDWARE FAILURE REQUIRING TIBIOTALOCALCANEAL ARTHRODESIS WITH IM NAIL IMPLANT(S) INVOLVED: 02.113.103, CORTEX SCREWS X 1 - 02.206.285. THIS COMPLAINT INVOLVES A TOTAL OF 12 IDENTIFIED PATIENTS. THIS PC IS CREATED TO CAPTURE SUBJECT ID (B)(6). THIS IS RELATED TO (B)(4).

  Patient problems: Malunion of Bone

  MAUDE report 22104185 ↗
• InjuryMay 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS COMPLAINT IS FROM A DATA USE AGREEMENT (DUA). THE DUA SUMMARIZES 116 PATIENTS THAT WERE IMPLANTED WITH THE LCP HOOK PLATE SYSTEM 3.5MM BETWEEN OCTOBER 2015 TO FEBRUARY 2023 AT SANFORD RESEARCH. SUBJECT ID (B)(6): PATIENT UNDERWENT FRACTURE FIXATION (OPEN REDUCTION INTERNAL FIXATION RIGHT ANKLE). INTRAOPERATIVE COMPLICATION INCLUDE: FASCIOTOMIES PERFORMED FOR COMPARTMENT SYNDROME DURING INDEX SURGERY.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 22104108 ↗
• InjuryMay 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS COMPLAINT IS FROM A DATA USE AGREEMENT (DUA). THE DUA SUMMARIZES 116 PATIENTS THAT WERE IMPLANTED WITH THE LCP HOOK PLATE SYSTEM 3.5MM BETWEEN OCTOBER 2015 TO FEBRUARY 2023 AT SANFORD RESEARCH. SUBJECT ID: (B)(6): A 73-YEAR-OLD FEMALE PATIENT WHO UNDERWENT FRACTURE FIXATION (OPEN REDUCTION INTERNAL FIXATION RIGHT ANKLE). POSTOPERATIVE COMPLICATIONS AND TREATMENT/INTERVENTION INCLUDE: MALUNION, HARDWARE FAILURE REQUIRING ANKLE ARTHRODESIS WITH INTERNAL AND EXTERNAL FIXATION. IMPLANT(S) INVOLVED: 02.113.103, UNKNOWN SCREWS X 2, K-WIRE - 292.12. THIS COMPLAINT INVOLVES A TOTAL OF 12 IDENTIFIED PATIENTS. THIS PC IS CREATED TO CAPTURE SUBJECT ID: (B)(6). THIS IS RELATED TO (B)(4).

  Patient problems: Malunion of Bone

  MAUDE report 22103705 ↗
• InjuryOct 21, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED ON UNKNOWN DATE THAT THERE WAS AN OPEN REDUCTION AND INTERNAL FIXATION OF LEFT INTRA-ARTICULAR DISTAL TIBIA AND FIBULA PILON FRACTURE.15 WEEKS POST OP: P/W INCREASED LEFT ANKLE PAIN AND SWELLING. X-RAYS DEMONSTRATED DISPLACEMENT OF THE MEDIAL MALLEOLUS FRACTURE AND PROTEIN SCREW FROM THE POSTEROLATERAL PLATE. 15 WEEKS POST OP: UNDERWENT LEFT ANKLE REVISION WITH AUTOGRAFT AND ALLOGRAFT DUE TO NONUNION. THIS REPORT IS FOR ONE (1) 3.5MM LCP HOOK PLATE 3 HOLE. THIS IS REPORT 2 OF 5 FOR COMPLAINT (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture; Pain; Physical Asymmetry; Swelling/ Edema

  MAUDE report 15649458 ↗
• InjuryOct 20, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE THERE WAS OPEN REDUCTION AND INTERNAL FIXATION OF MEDIAL, MIDDLE, AND LATERAL INTERCUNEIFORM JOINTS, OPEN REDUCTION AND INTERNAL FIXATION OF CUNEIFORM-NAVICULAR JOINT, OPEN REDUCTION AND INTERNAL FIXATION OF RIGHT LISFRANC'S JOINT, OPEN REDUCTION AND INTERNAL FIXATION OF 1ST METATARSAL, OPEN REDUCTION AND INTERNAL FIXATION OF 1ST TARSOMETATARSAL JOINT, OPEN REDUCTION AND INTERNAL FIXATION OF 2ND METATARSAL JOINT, OPEN REDUCTION AND INTERNAL FIXATION OF RIGHT BIMALLEOLAR ANKLE FRACTURE, OPEN REDUCTION AND INTERNAL FIXATION OF RIGHT SYNDESMOSIS, AND CLOSURE OF TRAUMATIC LACERATION. 18 WEEKS POST OP: LIKELY SURGICAL SITE INFECTION TREATED CONSERVATIVELY WITH BACTRIM, CIPROFLOXACIN, AND RIFAMPIN. 18 WEEKS POST OP: CONSERVATIVE TREATMENT OF SURGICAL SITE INFECTION LED TO RESOLUTION OF THE INFECTION. THIS REPORT IS FOR A 3.5MM LCP HOOK PLATE 3 HOLE. THIS IS REPORT 1 OF 4 FOR (B)(4).

  Patient problems: Post Operative Wound Infection

  MAUDE report 15642343 ↗
• InjuryOct 20, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THERE WAS OPEN REDUCTION AND INTERNAL FIXATION OF LEFT MEDIAL AND LATERAL MALLEOLUS. POSTFRACTURE ANKLE ARTHRITIS HAD OCCURRED. S/P LEFT ANKLE ARTHRODESIS SECONDARY TO POSTFRACTURE ANKLE ARTHRITIS HAD OCCURRED. THIS REPORT IS FOR ONE (1)UNK - SCREWS: CORTEX. THIS IS REPORT 10 OF 11 FOR COMPLAINT (B)(4).

  Patient problems: Arthritis

  MAUDE report 15639739 ↗
• InjuryOct 20, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THERE WAS OPEN REDUCTION AND INTERNAL FIXATION OF LEFT MEDIAL AND LATERAL MALLEOLUS. POSTFRACTURE ANKLE ARTHRITIS HAD OCCURRED. S/P LEFT ANKLE ARTHRODESIS SECONDARY TO POSTFRACTURE ANKLE ARTHRITIS HAD OCCURRED. THIS REPORT IS FOR ONE (1) 3.5MM LCP HOOK PLATE 3 HOLE. THIS IS REPORT 1 OF 11 FOR COMPLAINT (B)(4).

  Patient problems: Arthritis

  MAUDE report 15639474 ↗
• InjuryOct 20, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PATIENT UNDERWENT OPEN REDUCTION/INTERNAL FIXATION OF A RIGHT BIMALLEOLAR OPEN ANKLE FRACTURE. THREE WEEKS POST-OP, THE PATIENT PRESENTED WITH RIGHT ANKLE PAIN. PHYSICAL EXAM SHOWED PURULENCE COMING FROM THE LATERAL TRAUMATIC LESION, ALONG WITH SKIN BREAKDOWN AND EXPOSED HARDWARE, THUS SUSPECTING FOR ACUTE OSTEOMYELITIS OF THE RIGHT ANKLE SECONDARY TO AN OPEN FRACTURE. FOUR WEEKS POST-OP, THE PATIENT UNDERWENT INCISION AND DRAINAGE OF A SUSPECTED RIGHT ANKLE OSTEOMYELITIS AND APPLICATION OF A VAC DRESSING. 4 DAYS LATER, PATIENT UNDERWENT REPEAT INCISION AND DRAINAGE OF A SUSPECTED RIGHT ANKLE OSTEOMYELITIS AND APPLICATION OF A VAC DRESSING. 3 DAYS LATER, PATIENT UNDERWENT FINAL INCISION AND DRAINAGE OF A SUSPECTED RIGHT ANKLE OSTEOMYELITIS AND APPLICATION OF A VAC DRESSING. THIS REPORT INVOLVES ONE 3.5MM LCP HOOK PLATE 3 HOLE. THIS IS REPORT 1 OF 5 FOR (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 15639258 ↗
• InjuryOct 20, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PATIENT UNDERWENT OPEN REDUCTION/INTERNAL FIXATION FOR A RIGHT BIMALLEOLAR ANKLE FRACTURE WITH REPAIR OF SYNDESMOSIS. FOUR WEEKS POST OP, PATIENT HAD A 1MM OPENING IN THE MIDPORTION OF THE MEDIAL EXCISION WITH CLEAR, SEROSANGUINOUS DISCHARGE WITH NO ERYTHEMA. A 10-DAY COURSE OF AUGMENTIN WAS ADMINISTERED TO THE PATIENT. 6 WEEKS POST OP, 1MM OPENING HAD WIDENED AND A SCREW HEAD HAD BECOME VISIBLE. UNDER STERILE CONDITIONS, THE SCREW HEAD WAS REMOVED IN OFFICE, WITH WOUND IRRIGATION AND CLOSURE. PATIENT WAS CONTINUED ON AUGMENTIN FOR INFECTION PROPHYLAXIS. FOR THE REMAINDER OF THE FOLLOW UP, PATIENT DEMONSTRATED EXCELLENT REHABILITATION, PAIN CONTROL, AND NO SIGNS OF INFECTION. THIS REPORT INVOLVES ONE 3.5MM LCP HOOK PLATE 3 HOLE. THIS IS REPORT 1 OF 6 FOR (B)(4).

  Patient problems: Post Operative Wound Infection

  MAUDE report 15638920 ↗
• InjuryOct 20, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED ON AN UNKNOWN DATE THAT THERE WAS AN OPEN REDUCTION AND INTERNAL FIXATION OF RIGHT TALUS NONUNION OF THE TALUS, TIBIOTALAR ARTHRITIS, AND LIKELY AVN OF THE TALUS. FREE FIBULAR BONE GRAFT TO RIGHT TALUS FROM LEFT FIBULA FOR RIGHT TALUS NONUNION SECONDARY TO AVN. DUE TO SIGNIFICANT PAIN AND REDUCED RANGE OF MOTION POSTOPERATIVELY, SUBSEQUENTLY UNDERWENT RIGHT ANKLE ARTHRODESIS. THIS REPORT IS FOR ONE (1) 3.5MM LCP HOOK PLATE 3 HOLE. THIS IS REPORT 1 OF 4 FOR COMPLAINT (B)(4).

  Patient problems: Loss of Range of Motion; Necrosis; Nonunion/Delayed-union Bone Fracture; Pain

  MAUDE report 15638809 ↗
• InjuryOct 20, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE THERE WAS OPEN REDUCTION AND INTERNAL FIXATION; LEFT LATERAL AND MEDIAL MALLEOLUS WITH REPAIR OF THE LEFT SYNDESMOSIS, POSTOPERATIVE CT SCANS SHOWED ANTERIOR SUBLUXATION OF THE FIBULA WITHIN THE INCISOR OF THE TIBIA. REVISION SURGERY PERFORMED ON L ANKLE 6 DAYS POST OP TO PROPERLY REDUCE THE SYNDESMOSIS. THIS REPORT IS FOR ONE (1) 3.5MM LCP HOOK PLATE 3 HOLE. THIS IS REPORT 1 OF 4 FOR COMPLAINT (B)(4).

  Patient problems: Physical Asymmetry

  MAUDE report 15638570 ↗
• MalfunctionApr 2, 2021Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON (B)(6) 2021, DURING AN UNKNOWN ORTHOPEDIC PROCEDURE THE LOCKING SCREW STRIPPED OUT IN MOST PROXIMAL COMBO HOLE OF THE PLATE. THREADS OF THE COMBO LOCKING HOLE OF THE PLATE APPEARED TO BE DAMAGED AND WOULD NOT ACCEPT THE LOCKING SCREW. A NON LOCKING SCREW WAS USED IN ITS PLACE. THERE WAS NO SURGICAL DELAY. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT IS FOR ONE (1) 3.5MM LCP HOOK PLATE 3 HOLE. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11611303 ↗
• InjuryDec 10, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2020, THE PATIENT UNDERWENT A HARDWARE REMOVAL DUE TO INFECTION. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO SURGICAL DELAY. THE PATIENT STATUS IS UNKNOWN. THIS IS REPORT 2 OF 6 FOR (B)(4). THIS (B)(4) CAPTURES THE INFECTION POSTOPERATIVELY WHILE THIS (B)(4) CAPTURES THE SCREWS THAT BROKE DURING REMOVAL INTRAOPERATIVELY.

  Patient problems: Post Operative Wound Infection

  MAUDE report 10984389 ↗
• InjuryDec 8, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2020, THREE ELBOW PLATES AND SCREWS WERE REMOVED. THE PATIENT WANTED THE HARDWARE REMOVED. THE PROCEDURE OUTCOME WAS UNKNOWN. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT IS FOR ONE (1) 3.5MM LCP HOOK PLATE 3 HOLE. THIS IS REPORT 2 OF 4 FOR (B)(4).

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 10968740 ↗
• InjuryApr 3, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED ON (B)(6) 2019, A PATIENT UNDERWENT REMOVAL OF VARIABLE ANGLE LOCKING COMPRESSION LATERAL DISTAL FIBULA PLATE, LOCKING COMPRESSION PLATE HOOK PLATE AND UNKNOWN LOCKING SCREW DUE TO DISCOMFORT. THERE WAS NO SURGICAL DELAY. PROCEDURE WAS SUCCESSFULLY COMPLETED. PATIENT WAS FINE. THIS REPORT CAPTURES THE POSTOPERATIVE EVENT OF DISCOMFORT, WHILE THE INTRAOPERATIVE ISSUE OF SCREWDRIVER SHAFT BREAKAGE DURING HARDWARE REMOVAL IS CAPTURED UNDER RELATED COMPLAINT (B)(4). THIS REPORT IS FOR ONE (1) 3.5MM LCP HOOK PLATE 3 HOLE. THIS IS REPORT 2 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: Discomfort; No Code Available

  MAUDE report 8479670 ↗
• InjuryFeb 15, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2019, A PATIENT UNDERWENT REMOVAL OF A LOCKING COMPRESSION PLATE (LCP) LATERAL DISTAL FIBULA PLATE, LOCKING COMPRESSION PLATE (LCP) HOOK PLATE THREE HOLE, UNKNOWN SIX (6) CORTEX SCREWS AND UNKNOWN FOUR (4) LOCKING SCREWS DUE TO INFECTION AND NON UNION WITH SIGNIFICANT BONE LOSS. ALL DEVICES WERE REMOVED SUCCESSFULLY AND AN UNKNOWN EXTERNAL FIXATION WAS IMPLANTED. ORIGINAL PROCEDURE WAS AN OPEN REDUCTION INTERNAL FIXATION (ORIF) ANKLE SURGERY ON(B)(6) 2018 AT THE SAME FACILITY. IT IS UNKNOWN IF THERE WAS SURGICAL DELAY. PROCEDURE OUTCOME AND PATIENT STATUS ARE UNKNOWN. THIS COMPLAINT INVOLVES FOUR (4) DEVICES. THIS REPORT IS FOR ONE (1) 3.5MM LCP HOOK PLATE 3 HOLE. THIS REPORT IS 2 OF 4 FOR (B)(4).

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 8344788 ↗