| Device Type ID | 1277 |
| Device Name | Plate, Bone |
| Regulation Description | Bone Plate. |
| Regulation Medical Specialty | Dental |
| Review Panel | Dental |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Anesthesiology, General Hospital, Infection Control, And Dental Devices (DAGRID) Dental Devices Branch (DEDB) |
| Submission Type | 510(k) |
| CFR Regulation Number | 872.4760 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | JEY |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | Yes |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 1277 |
| Device | Plate, Bone |
| Product Code | JEY |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Bone Plate. |
| CFR Regulation Number | 872.4760 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
BIOMET | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
BIOMET MICROFIXATION | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
FLEXTRONICS INTERNATIONAL USA, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
IMPLADENT, LTD. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
JEIL MEDICAL CORPORATION | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
KARL LEIBINGER MEDIZINTECHNIK GMBH & CO. KG | ||
SUBSTANTIALLY EQUIVALENT | 4 | |
KLS MARTIN GMBH And CO. KG | ||
SUBSTANTIALLY EQUIVALENT | 4 | |
MATRIX SURGICAL HOLDINGS, LLC/MATRIX SURGICAL USA | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
OSTEOMED | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
OSTEOMED L.P. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
OSTEONIC CO., LTD. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
STRYKER | ||
SUBSTANTIALLY EQUIVALENT | 7 | |
STRYKER CORP. | ||
SUBSTANTIALLY EQUIVALENT | 7 | |
SURGIDENT | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
VISIONARE LLC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Break | 517 |
Adverse Event Without Identified Device Or Use Problem | 444 |
Fracture | 218 |
Insufficient Information | 90 |
Material Fragmentation | 63 |
Migration Or Expulsion Of Device | 58 |
Unintended Movement | 56 |
Material Deformation | 49 |
Device Operates Differently Than Expected | 44 |
Device Inoperable | 44 |
Difficult To Insert | 38 |
Inadequacy Of Device Shape And/or Size | 29 |
Device-Device Incompatibility | 23 |
Loose Or Intermittent Connection | 18 |
Malposition Of Device | 18 |
Screw | 16 |
Patient-Device Incompatibility | 15 |
Failure To Adhere Or Bond | 12 |
Appropriate Term/Code Not Available | 12 |
Detachment Of Device Or Device Component | 12 |
Material Protrusion / Extrusion | 12 |
Fitting Problem | 11 |
Device Dislodged Or Dislocated | 11 |
Difficult To Position | 9 |
Noise, Audible | 8 |
Dull, Blunt | 8 |
Device Markings / Labelling Problem | 7 |
Metal Shedding Debris | 7 |
Osseointegration Problem | 7 |
Bent | 7 |
Device Operational Issue | 6 |
Failure To Advance | 6 |
Biocompatibility | 6 |
Manufacturing, Packaging Or Shipping Problem | 6 |
Plate | 6 |
Detachment Of Device Component | 5 |
Difficult To Remove | 5 |
Material Twisted / Bent | 5 |
Use Of Device Problem | 5 |
No Apparent Adverse Event | 4 |
Migration | 4 |
Expulsion | 4 |
Device Slipped | 4 |
Device Expiration Issue | 4 |
Device Or Device Fragments Location Unknown | 3 |
Premature Separation | 3 |
Device Issue | 3 |
Patient Device Interaction Problem | 3 |
Sticking | 3 |
Loss Of Osseointegration | 3 |
Extrusion | 3 |
Connection Problem | 2 |
Biofilm Coating In Device | 2 |
Physical Property Issue | 2 |
Tip | 2 |
Material Integrity Problem | 2 |
Failure To Osseointegrate | 2 |
Biological Environmental Factor | 2 |
Peeled / Delaminated | 2 |
Loosening Of Implant Not Related To Bone-Ingrowth | 2 |
Device Damaged By Another Device | 2 |
Material Separation | 2 |
Difficult To Advance | 2 |
Naturally Worn | 2 |
Labelling, Instructions For Use Or Training Problem | 2 |
Failure To Align | 2 |
Defective Device | 1 |
Mechanical Problem | 1 |
Packaging Problem | 1 |
Malfunction | 1 |
Material Distortion | 1 |
Positioning Problem | 1 |
Positioning Failure | 1 |
Separation Failure | 1 |
Component Or Accessory Incompatibility | 1 |
Mechanical Jam | 1 |
Device Handling Problem | 1 |
Dent In Material | 1 |
Human-Device Interface Problem | 1 |
Material Discolored | 1 |
Product Quality Problem | 1 |
Unstable | 1 |
Improper Or Incorrect Procedure Or Method | 1 |
Structural Problem | 1 |
Failure To Cut | 1 |
Disassembly | 1 |
Particulates | 1 |
Retraction Problem | 1 |
Material Split, Cut Or Torn | 1 |
Difficult Or Delayed Positioning | 1 |
Delivered As Unsterile Product | 1 |
| Total Device Problems | 2009 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Synthes (USA) Products LLC | II | Jun-07-2016 |
| 2 | Synthes (USA) Products LLC | II | Jul-28-2015 |
| 3 | Zimmer Biomet, Inc. | II | May-07-2018 |